Tag: Design Controls

 

When you scale your Design Controls appropriately to the complexity and size of your company, it makes it easier to manage the scope of everyday work needed to keep your files current. Things to remember when scaling your Design History Files (DHF):

 

  • One size does not fit all
  • All classes of devices need design controls
  • The process is scaled based on the complexity of the device and the size of the company
  • Don’t wait for the regulators to identify any gaps

 

Also, identifying your gaps up front, closing them upon identification, then wrapping them into your entire DHF process with your team or with a third-party consultant like RCA helps ensure you have a rock-solid DHF and that you will be prepared when the regulators ask questions.

 


Click to listen to RCA’s full DHF & Design Control podcast Here!


 

FDA Design Control

 

RCA offers medical device consultants who will help you navigate through new product development and remediating legacy Design History Files (DHF). Our life science consultants have a thorough understanding of the specific design history requirements for U.S. and international medical device industries. We’ll support your team’s ability to ensure regulatory compliance and accelerate medical device DHF best practices.

 

In addition to DHF content, development, and management, download our handout to view more of our DHF-related support services, including:

 

  • FDA design control requirements
    • Quality System Regulation, 21 CFR Part 820
    • Design control medical device CGMPs and 21 CFR 820.30
    • Device Master Records (DMR)
    • Device History Record (DHR)
  • ISO 13485 design control
    • Design control procedures
    • Design control process evaluation
    • Design control documents
    • Design quality control
  • The EU’s Medical Device Regulations (MDR) including Technical File / Design Dossier
  • Risk management (ISO 14971) for medical devices including risk analysis, FMEA, risk evaluation, and risk controls through Corrective and Preventive Action (CAPA) plan and design control requirements
  • IEC 60601-1-11 (2010) including Programmable Electrical Medical Systems (PEMS) (Clause 14)
  • Total product life cycle (TPLC)
  • AAMI design control

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

DHFRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Click now to watch Regulatory Compliance Associates® Dr. Stephen Coulter explain how design controls and risk management play an intricate role in the Waterfall methodology:

 

 

The Waterfall methodology incorporates the usage of FDA design controls into the medical device design process. It serves as the primary connection between quality system requirements (QSR) and current good manufacturing practices (CGMP).

 

Waterfall Method

 

Conceptually, the FDA Waterfall model is designed to provide engineers with the flexibility to mitigate product risk, meet regulatory compliance and satisfy customer needs. It is a sequential process based on the quality assurance and medical device engineering principles listed in 21 CFR 820. The methodology itself is conceptualized in the image below from the Medical Device Bureau of Health Canada. 

 

Waterfall Development

 

To increase risk mitigation during the Waterfall methodology, both risk management & design controls are considered. They often become integrated processes during Waterfall product development. Many unique tools that medical device engineers use to define requirements & meet user needs are shared across these processes, even though each is based on a separate standard.

 

While design controls for FDA approval are referred to in 21 CFR 820, medical device risk management is internationally associated with ISO 14971. Three critical elements of risk mitigation strategies clearly focus on avoiding risk during product development:

 

  • Evaluating an associated risk
  • Controlling an evaluated risk
  • Monitoring risk control effectiveness overall

 

Input Requirements

 

The success of the Waterfall development method depends on early research & assessments conducted about input requirements that include strategic risk. Further, spending time documenting the inputs of user interface, user stories and product epics can help increase positive outcomes and reduce requirement risk overall.  Finally, any inconsistencies during the waterfall methodology between the proposed design & input requirements can be corrected across stages. This aligns with one of the primary motivations behind FDA originally developing 21 CFR 820 (e.g. helping medical device manufacturers find design deficiencies earlier in the process).

 

Risk Management

 

By starting the Waterfall process with this end state in mind, design inputs are more likely to pass failure testing & become a manufacturing output. This risk management strategy during a Waterfall project can begin with identifying the publicly known risks of competitive products. Second, the team is challenged to investigate if similar hazards could be associated with your medical device. When working with a Regulatory Compliance Associates risk management consultant, our clients are reassured that Waterfall development should detail how hazards can impact user needs & potential customers.

 

For example, design inputs should consider current regulations and global standards early in the waterfall process. This helps incorporate a risk management perspective even before verification and validation testing begins. Intended uses should consider predicate devices and if any causes for recalls are related to design, materials, or software. 

 

Waterfall Approach

 

So, does this mean risk management & design controls are connected in the waterfall approach? And if they are, how important is one over the other when leading to marketing approval or regulatory compliance? This process is often measured against a combination of factors, including:

 

  • Regulations & standards for clinical approval
  • Risk class of medical device being manufactured
  • Regulatory body reviewing the marketing submission

 

Enterprise risk management would consider all three of these factors individually and in combination when considering how to eliminate systemic risk. The Waterfall project management team can also use various tools and techniques while developing the risk management plan. These risk identification tools include conducting a risk analysis, performing an FMEA, and charting risk tolerance. 

 

Risk Analysis

 

Existing regulations & standards offer various types of risk tools that can be incorporated into design controls. This can include identifying risk levels and creating severity charts during the user needs & design inputs stages. Additionally, each new product will have different hazards and risk tolerance levels associated with the target patient. Being able to analyze the problem, control the problem, and mitigate the risk is essential to define in your risk analysis. Challenge yourself to reduce and identify hazards by analyzing the known data as much as possible.

 

FMEA

 

Failure Mode and Effects Analysis (FMEA) is a controlled technique to detect & concentrate on budding trouble. Each failure is commonly assigned a rating based on the negative effect it may cause. The Waterfall process would then take each rating and project how the marketplace, healthcare systems, or patients can be impacted. FMEAs are one of many risk mitigation tools that can help your team identify the hazards of your severity chart. Each charted hazard is established based on the severe nature of the hazard to the user and project requirements for design control.

 

Risk Tolerance

 

Further, after the severity is defined, all known or projected hazards can be developed into a risk tolerance chart. The risk tolerance chart can then be shared cross-functionally across the team to help everyone understand which design steps can increase user risk. One of the benefits of a risk tolerance chart is being able to show data visualization. The design team should consider how design controls and user needs can reduce the hazard’s impact. Finally, a waterfall chart could also project the negative consequences of adverse events and what the estimated cumulative impact might be during a product crisis scenario.

 

Risk Management Summary

 

Finally, once your team has evaluated the risks and decided on precautions, a risk management summary is developed. It may include involves multiple failure mode analysis types (e.g. product, process, etc.) and risk ratings. These initial ratings are typically based on the types of failures and the severity of the failure itself. Ranges can also be given to determine the risk management strategy and what is the acceptable level of product risk (e.g. high, medium, low).

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Join Regulatory Compliance Associates (RCA) along with our colleagues from Nelson Labs and Sterigenics will be exhibiting at this year’s BIOMEDevice Silicon Valley expo in Santa Clara, California, on November 15th and 16th. Visit us in booth # 1142 to connect with experts from each of our teams to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

On Thursday, November 16 at 11:00am, Regulatory Compliance Associates’ Dr. Stephen Coulter will be presenting an in-depth overview of the Waterfall model and addresses the question, Are Risk Management and Design Controls two different processes? You’ll learn more about incorporating risk management strategies into user needs and design inputs, as well as how validating both will accelerate the success of your design review process.

Add Dr. Coulter’s presentation to your show planner by following the link here

About BIOMEDevice Silicon Valley

From digital health to surgical robotics, BIOMEDevice is the starting point for the discovery of progressive solutions to challenges and impactful products. We bring together engineers, business leaders, disruptive companies and innovative thinkers from the top start-ups and medical device OEMs together to inspire and collaborate on the next lifechanging medical device. Our community comes together in Silicon Valley the #1 MedTech hub in the country to share new innovationseducate each other on what’s new in the industry, collaborate on new ideas, and partner to move the industry forward.

Register Now

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

BIOMEDeviceRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

The International Medical Device Regulation Forum (IMDRF) recently published updated cybersecurity guidance for the medical device industry. The medical device cybersecurity working groups at IMDRF have been busy lately, publishing multiple final documents about medical devices & software as medical device (SaMD). 

 

Regulatory Compliance

 

IMDRF’s medical device guidance provides steering assumptions for both regulatory compliance & medical device cybersecurity, which are appropriate for sponsors developing medical devices. Further, a primary objective of the guidance is simultaneously increasing patient safety & reducing external threats for providers and HCPs.

 

Global Harmonization

 

The guidance begins with harmonization concepts that could affect multiple departments inside a medical device manufacturer. Additionally, key areas for harmonization programs highlighted by the cybersecurity guidance include:

 

  • Product design
  • Risk management activities
  • Device labelling
  • Regulatory submission
  • Information sharing
  • Post-market activities

 

Product Life Cycle (PLC)

 

IMDRF’s cybersecurity guidance continues on with a deeper evaluation of risks associated across the product life cycle. It is recommended for potential vulnerabilities to be considered for any product life cycle stage, especially considering legacy devices that may be vulnerable to strategic risk. 

 

 

Product Design

 

Product design considerations include the initial phases of medical device development and continues until the end of support (EOS) once a product is discontinued. The four product design stages the cybersecurity guidance refers to when it comes to total product life cycle:

 

  • Development Stage
  • Support Stage
  • Limited Stage
  • End of Support

 

Development Stage (Stage 1)

 

The Development Stage occurs during the pre-commercialization phase before a medical device is approved by a regulatory body. This is when medical device manufacturers begin to incorporate security into the product concepts being designed. Design controls are critical in this stage for medical device manufacturers to leverage when considering how to mitigate risks.

 

Finally, an important deliverable of the Development Stage is product-related security documentation. The documentation is designed to help unfamiliar users to understand how to securely operate the medical device. 

 

Support Stage (Stage 2)

 

The Support stage is during the initial post-launch phase and may continue for many years. Medical devices in this stage are:

 

  • Currently used for providing patient care
  • Available for purchase on the open market
  • Contain major software, firmware, or programmable hardware components
  • Support for software, firmware or components is provided by the medical device manufacturer

 

Additionally, medical devices in the Support stage should receive full cybersecurity support. This support often includes software patches, software updates, hardware updates, and incremental support the manufacturer considers appropriate.

 

Limited Support Stage (Stage 3)

 

Medical device manufacturers continue to provide cybersecurity support during Stage 3. However, as product development transitions to a more current medical device design, different constraints are involved with the transition. Medical devices in Stage 3 often require additional network controls compared to medical devices in Stage 2:

 

  • Third-party components or software may be used more frequently than internally developed updates or patches
  • Cybersecurity best practices integration is often governed by the ease of following support practices outlined in the Stage 2
  • Medical device manufacturers must explain to users the existing limitations that are now recognized in the devices and services affected
  • Healthcare providers using the medical device should begin to take more of an active role in unmitigated features of security defense.

 

End of Support Stage (Stage 4)

 

Medical devices in Stage 4 are considered more vulnerable than any of the other stages. They may still be in use for providing patient care, but they have been publicly identified as no longer being supported by the medical device manufacturer. Each of these scenarios result in a medical device that cannot be consistently defended against modern cybersecurity dangers.

 

Critical facets healthcare information technology departments should look for include:

 

  • Medical devices that have been declared EOS by the medical device manufacturer
  • Medical devices that are not actively marketed or sold by the medical device manufacturer
  • Medical devices that contain software, firmware, or programmable hardware components no longer supported by software developers
  • Medical devices with known risks to device safety and effectiveness that are unmitigated

 

Risk Management

 

risk managementFurther, the guidance calls for a risk management approach to product lifecycle management featuring:

 

  • Security risk analysis
  • Security risk evaluation
  • Security risk control
  • Security risk acceptability

 

The cybersecurity guidance expands on product design and how security is incorporated and maintained through the product life cycle. This can be accomplished through using risk control and a secure development framework.

 

Risk mitigation recommendations for medical device manufacturers include:

 

  • Security design and controls based on intended use of the medical device
  • Security risk assessments across the risk management process
  • Threat modelling to help determine operational risk

 

Security testing and communication for medical device manufacturers include:

 

  • Customer facing product security documentation & communication
  • Post-market monitoring of cybersecurity vulnerabilities
  • Identification of vulnerabilities in third party risk management
  • Vulnerability risk identification based on the device security design, controls, and mitigations

 

Ensuring availability of security patches & mitigations based on device risk:

 

  • Coordinated and clear communication to all affected users
  • Description related to the vulnerability and its corresponding mitigations
  • Identification of other mitigation options when a security patch is unavailable

 

Data Integrity

 

One of the core principles the guidance stresses is cybersecurity information, data integrity and the importance of information sharing. IMDRF encourages medical device industry stakeholders to implement a proactive pre- and post-market approach to cybersecurity information sharing.

 

Moreover, timely information can help the industry recognize threats, evaluate associated risks, and react quickly as needed. An increase in industry transparency could directly benefit healthcare providers, medical device users and medical device companies.

 

Security Updates

 

An important section of the medical device cybersecurity guidance details stakeholder responsibilities related communications, risk management, and transfer of responsibility. Specifically, it is important that medical device manufacturer communications are comprehensive & identify types of documentation needed and when the medical device user may need it. 

 

Product Security Documentation

 

Medical device manufacturers should ideally provide PLC documentation about security or support changes early in the Support stage. This helps HCP risk management during both the procurement & deployment of medical devices. Types of life cycle support for product security documentation includes:

 

  • Manufacturer disclosure statement for medical device security
  • Software Bill of Materials (SBOM)
  • Security test report summaries
  • Third-party security certifications
  • Customer security documentation

 

Product Life Cycle Documentation

 

Medical device companies should communicate the strategic life cycle milestones to their customers. Further, these interactions would include cybersecurity EOL and EOS dates if available. This helps to support HCPs during both the procurement & installation process.

 

Additionally, medical device manufacturers should provide this information as far in advance as possible. The goal is at least 2 years in advance to best support healthcare professionals with the following information:

 

  • Affected medical devices
  • Medical device operating system(s)
  • Version of medical device deployed
  • Medical device software components
  • Expected date of medical device service changes
  • Extent of medical device maintenance after a service change occurs
  • Additional design controls that help all involves parties

 

Vulnerability & Patching Information

 

If a vulnerability is uncovered, medical device companies should provide related vulnerability information. Further, the guidance specifically mentions the importance of both the appropriate mitigation or available software patch. Additionally, the guidance stresses an elevated priority be placed on high-risk vulnerabilities where timely communication is required. This communication is designed to help prevent both patient injury or device interruption.

 

Finally, the mitigation method and implementation instructions should be provided to the medical device operators. These security updates include both an over-air update or deployment of service personnel to help install the remedy.

 

Proactive Communications for Third-Party Components

 

Medical device software and other digital components within a medical device will reach EOL/EOS before the product itself does. In these cases, risk can increase based on the lack of support for these elements. To help compensate for these security risks, the cybersecurity guidance suggests medical device companies should:

 

  • Validate the list of third-party components used in medical devices
  • Track support status updates of third-party components used within their device
  • Assess the risks that exist when third-party components become unsupported
  • Communicate new risks and available risk mitigations to healthcare providers

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Click now to learn from Sue Schniepp, Distinguished Fellow at Regulatory Compliance Associates, as she describes microbial process design and how your team can improve contamination control. 

 

 

Human microbes live in every part of a human being, including the skin, gut, and nose. Trillions of microorganisms live inside the human body — often outnumbering human cells by 10 to 1. However, microorganisms only make up roughly 1 to 3 percent of the body’s mass because of their tiny size. Sometimes microbes in food can lead to illness, but it is more common for microbes in human body functions to safely live in their host. Additionally, many types of microbes provide unique qualities that help increase life expectancy and human survival in general.

 

Annex 1

 

microbial process designWhen it comes to microbial control and process design, there are unique drivers listed in the EU’s Annex 1 regulatory guidance that can help your organization. This regulatory compliance guidance contains different types of contamination control requirements.

 

Further, these drivers come in many different shapes and sizes, but all can impact manufacturing production if not carefully considered.

 

Sterile Preparations

 

Manufacturing sterile products covers a wide spectrum of decisions to be considered by the Quality team and manufacturing operations, including:

 

Sterile product types

  • Active substance
  • Sterile excipient
  • Packaging material
  • Finished dosage form

Packaging sizes

  • Single unit
  • Multiple units

Sterile processes

  • Automated systems
  • Manual processes

Technologies

  • Biotechnology
  • Small molecule manufacturing
  • Closed systems

 

Additionally, one of the quality assurance goals of sterile product manufacturing is to minimize risk associated with microbial, particulate, and pyrogen contamination.

 

Process Design

 

Contamination sources are the focus of process design and are commonly due to microbial and cellular debris, as well as particulate matter. Understanding how your facility, equipment and employees contribute to uncleanness (whether intentional or not) is essential to contamination control. Lastly, process design should consider each contamination source individually and as a whole to achieve regulatory compliance.

 

Manufacturing Plant

 

The facility your product is manufactured in is the first gap analysis that should be conducted. For example, a food manufacturing plant will have a different set of needs to be considered than a pharmaceutical manufacturing environment. Each will have unique requirements based on equipment, environment and process. Further, pharmaceutical production follows unique FDA guidance recommendations that are unlike many commercialized products on the market.  

 

Cleanroom

 

One of the first priorities your team should understand is clean room classifications and differences in a regulated clean room environment. There are many types of cleanroom services that can help with clean room design and preparing for regulatory compliance (e.g. ISO 7 or ISO 8).

 

For example, cleanliness standards and cleanroom supplies should be maintained and monitored for environmental conditions. Finally, airlocks for both personnel and equipment should include HEPA (High Efficiency Particulate Air) air filtration to increase air cleanliness and controls that reduce contaminants.

 

RABS

 

Restricted Area Barrier Systems (RABS) and isolators can help assure environmental conditions help minimize microbial contamination. Further, a reliable containment strategy should consider the types of human intervention that can impact the critical zone. This often goes hand-in-hand with the type of grade the zone is.

 

There are four primary types of critical zones:

 

  • Grade A: this area includes high risk operations that must consider air filtration, the aseptic processing line, and filling zone. Additionally, the stopper bowl, open ampoules and vials also must be studied based on contaminates & unidirectional air flow. Finally, process design & SOPs should minimize the number of operators who don’t use barrier protection or glove port
  • Grade B: this area is commonly a background cleanroom for Grade A aseptic preparation and filling zone. Most importantly, airflow visualization studies should show that air does not enter from any lower grade cleanrooms to Grade B. Air pressure differentials should be monitored to ensure clean airflow.
  • Grade C and D: These types of cleanroom spaces are used for lower risk manufacturing stages in the manufacturing process. The most often use class for Grade C and D are the preparation and filling of terminally sterilized

 

Finally, it is critically important when analyzing the grade of a zone when it comes to modular clean room or portable clean room designs. Make sure your cleanroom construction team understands the types of certified cleanroom principles that follow regulatory compliance.

 

Water Systems

 

A water treatment plant is one of the most critical elements of microbial process design. The water filter system should minimize both particulates and pyrogens to help reduce the potential for contamination. Further, special attention should be given to the different types of water filter products used & how they are monitored and maintained over time. Nevertheless, water flow should remain forceful & consistent through water filtration pipes to minimize microbial adhesion & the risks associated with biofilm formation.

 

Sterilizing Agent

 

When using a pure steam generator as a sterilizing agent, the design should be correctly purified. Additionally, these agents of sterilization should be designed & validated to confirm steam quality meets both chemical levels and endotoxin levels. For the same reason, measure your steam quality for any additional additives that can cause either contamination of your product or manufacturing equipment.

 

Central Vacuum System

 

Understanding when gases come into contact with the product or container surfaces is critical during process design. For example, here are process design concepts to validate proper chemical, particulate, and microbial quality:

 

  • Relevant parameters (e.g. oil and water content) should be specified in the documentation
  • Consider the use cases inside the facility & type of gas being used during the process
  • Respect the gas generation system & if the design complies with the Pharmacopoeia monograph

 

Gases used in aseptic processes should always be filtered through a sterilizing filter. If your sterilizing filter is used on a batch basis, consider integrity testing the results during batch certification. Finally, any backflow from vacuum systems or pressure systems can produce hazards to the product. Have your quality team consistently review the mechanisms that prevent backflow when the systems are shut down.

 

Hydraulic Systems

 

Manufacturing equipment connected by hydraulics or heating & cooling systems, when possible, should be preferably outside the filling room. Equally important, pump hydraulics or fluid hydraulics located in the filling room should include design controls to contain any spillage. Leaks from these types of systems could pose a contamination risk to the product that should be detectable.

 

Finally, incorporating an indication system can help monitor leakage scenarios where contamination can become an urgent problem. This can include manufacturing technology such as tank gauges, a tank level sensor, and advanced water level monitor functionality. 

 

About RCA’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our regulatory compliance clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

 

Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

 

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:

 

 

When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority” setting a target date of December 2023 to finalize the rule.

 


Do you need ISO13485 compliance support? Talk to our Experts.


 

QMS Harmonization

 

Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.

 

Quality Management System

 

Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.

 

Risk Management

 

The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.

 

These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.

 

ISO Standard

 

With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.

 

Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.

 

ISO 13485:2016

 

ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:

 

  • Design controls and development
  • Production and manufacturing
  • Storage and distribution
  • Installation
  • Servicing a medical device
  • Technical support

 

ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates can help guide you through any stage of the medical device consulting process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

  • SaMD Consulting
  • Threat Modeling
  • Proof of Concept
  • Quality Assurance Services
  • TIR 57 & TIR 97
  • ISO 62304
  • ISO 27001

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Services

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

medical device consultingRegulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, Regulatory Compliance Associates can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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