Tag: cybersecurity fda

FDA Harmonization

Posted on by Joby Semmler

The FDA harmonization team has recently announced it is no longer going to be a member of the Global Harmonization Working Party (GHWP). This comes as an eye-opener for many life science industry employees since FDA harmonization has been a visible priority since the agency joined GHWP in 2021.

 

The FDA stated that it will continue to work with global regulatory experts on international harmonization, with the primary partner being the International Medical Device Regulators Forum (IMDRF).

 

Food and Drug Administration

 

Some industry executives have asked the question why take this type of action now? One primary reason many life science industry experts believe the time is right is based on the Center for Devices and Radiological Health (CDRH) strategic plan launched in late 2023. Inside the details of the document, the Food and Drug authority laid out a four-year example timeline for working towards greater international harmonization.

 

These are a few of the initiatives listed to be achieved by FY 2027:

 

FDA Timeline

 

Each fiscal year, CDRH will now evaluate different types of opportunities to increase engagement across international harmonization programs. Further, it is anticipated that CDRH will receive additional funding and resources to help accelerate this engagement. These additional resources will be designed to allow the FDA to expand international harmonization and convergence programs already in progress. 

 

Best Practices

 

The second phase of the strategic plan is designed to increase discussions about the implementation of harmonized policies. Further, this new mechanism may require FDA to develop additional confidentiality agreements to increase the efficiency of research analysis & discussion under confidentiality commitments. CDRH will review the current list of approved regulatory partners and confidentiality protocols in place to align regulatory strategies across international agencies. 

 

Medical Research

 

Per the strategic plan, FDA will identify and begin engaging with regulatory authorities by the end of 2023. The primary objective is to create a database of regulatory bodies with whom sharing medical research could be most helpful toward the global harmonization of standards. Finally, CDRH has committed to creating this information-sharing mechanism to communicate best practices in medical device evaluation by the end of 2024. 

 

Technical Documents

 

The strategic plan goes on to elaborate on how CDRH’s regulatory policy compares to widely accepted IMDRF policies. Furthermore, technical specifications of IMDRF documents that include policies and practices approved by all regulatory authorities in the IMDRF Management Committee will be assessed and evaluated by FDA.

 

One goal of this regulatory process is to increase the understanding of technical description and technical report writing of international regulatory agencies. This will directly help CDRH with their internal assessment of international harmonization efforts, and how FDA’s process may differ in comparison to regulators around the world.

 

FDA Analysis

 

Based on the technical specification data listed in the strategic plan, these are the proposed timelines for CDRH to make advances toward global harmonization:

 

  • CDRH will publish an assessment of at least nine IMDRF technical documents by the end of 2025.
  • CDRH will publish an assessment of at least 18 IMDRF technical documents by the end of FY 2026.
  • CDRH will publish an assessment of all remaining IMDRF technical documents by the end of FY 2027

 

Regulatory Authority

 

The strategic plan continues to elaborate on the life science community and the impact non-FDA employees can have on future regulatory approval. These specific stakeholders may have a unique perspective based on their current occupation or the types of therapy a patient receives. Finally, the following audiences are specifically mentioned for providing first-hand experiences that FDA can leverage based on another regulatory authority’s approach to medical therapy. 

 

  • Healthcare patients
  • Life science manufacturers
  • Conformity assessment bodies
  • Standards development organizations

 

Patient Engagement

 

Finally, an annual communication plan is proposed to begin in 2024 that includes developing a forum to assess and report on harmonization program efforts in progress. This forum will be designed to connect with each of the audiences mentioned above to help FDA identify opportunities for learning. Furthermore, this forum would be dependent on the level of interest and considerations of other stakeholders, including the life sciences industry specifically. 

 

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. Our pharmaceutical consulting Experts will create a customized approach depending on your product and 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. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, 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. Finally, our regulatory compliance services team excels in transferring continuous improvement 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

 

fda harmonizationRegulatory 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, 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 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. 

Medical Device Cybersecurity Guidance

Posted on by Joby Semmler

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. 

 

 

Pharmaceutical Supply Chain Consulting

Posted on by Joby Semmler

About Regulatory Compliance Associaties

 

Regulatory Compliance Associates (RCA® ) provides pharmaceutical supply chain 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, supply chain, 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.

 

RCA Pharmaceutical Supply Chain Consulting Services

 

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

 

Assessments 

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services includes:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits 

 

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response 

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness 

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

Data Integrity

 

Training:

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting:

 

  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

cGMP Consulting

 

Maintaining data integrity is an important part of ensuring the manufacturing quality of your pharmaceutical. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.

 

In a time when compromised data has become a common concern among businesses in the life science field, it’s become more critical than ever to maintain healthy practices concerning data storage and release. Medical device companies of all sizes and types need to trust their data’s integrity, which is why thousands of businesses have turned to Regulatory Compliance Associates® for GMP quality compliance services.

 

With a team of more than 500 industry experts and seasoned veterans of the FDA, we know what it takes to adhere to the standards of global regulatory bodies. We offer the expertise needed to help your business stay within cGMP and preserve your data’s integrity. Our array of training and consulting services will ensure that your customers’ trust in your brand is well-placed.

 

GMP Quality Compliance Services

 

Training

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting

 

  • cGMP Consulting
  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with the execution of Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of your medical device—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

Manufacturing Processes

 

Our comprehensive evaluations will identify GMP pharmaceutical practices that consistently yield a sustainable return on investment. We will help you identify opportunities for:

 

  • Reducing Set-Up Times
  • Increasing Throughput
  • Reducing Inventory Levels
  • Lab Efficiency Improvements
  • Scrap and Waste Reduction
  • Cycle Time Compression
  • Capacity Creation
  • Process Automation
  • Cost Reduction

 

Manufacturing Optimization

 

Regulatory Compliance Associates provides the following manufacturing optimization services:

 

  • Program Analysis
  • Process Optimization through Engineering Studies
  • Statistical Process Control
  • Lean Innovative Product / Process Solutions
  • Value Stream Mapping
  • Kaizen Events
  • Design for Six Sigma
  • Inventive Problem Solving

 

Automated Industrial Services

 

Regulatory Compliance Associates  provides manufacturing automation consultants with deep industry experience including:

 

  • Validation Master Plan
  • Development of Validation Documentation
  • Validation Services
  • Risk Assessments

 

Factory Automation

 

Regulatory Compliance Associates helps clients develop innovative factory automation via design strategy and hands-on validation support. We ensure that updating manufacturing facilities will continue to meet all regulatory and client requirements, without an adverse impact on the finished product.

 

  • HVAC Systems and Associated Controllers
  • Medical Gas Systems
  • Plant and Pure Steam Systems
  • Water Systems including USP, RO / DI, and WFI
  • Compressed Air Systems
  • Controlled Environments

 

Pharmaceutical Contract Manufacturing

 

When you choose Regulatory Compliance Associates as your pharmaceutical manufacturing consultant, you’ll have the support of validating every contract manufacturer. RCA provides the combined skills and knowledge of more than 500 pharmaceutical and medical device experts who are experienced at working on the front lines of regulatory requirements. RCA clients benefit as these solutions move suppliers toward a culture of quality, from startups to Fortune 100 international enterprises.

 

Quality Management System

 

To create a positive change in the lives of patients counting on the availability of your product, you need to recognize the regulatory pathways of drug manufacturing companies that are ahead of you. Further, this includes the evolving technical development of your quality management system. When you work with us, you get a team that tailors its services to the comprehensive needs of your company. And that’s how you can be assured you’ll always receive the support you need to implement corrective action wherever it may be needed.

 

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. 

 

 

Medical Device Regulatory Preparation

Posted on by Brandon Miller

What can life science companies do to prepare themselves in the current medical device regulatory environment?

 

 

In this sound bite from RCA Radio, host Brandon Miller is joined by Jordan Elder, RCA’s Director of Regulatory Affairs, and Kinga Demetriou, an Expert Certifier at BSI, as they discuss what companies can do to properly prepare themselves for success in the current regulatory environment.

 

  • Take a look at your product and make sure your regulatory strategy is conducive to your particular product and market. Have a pathway forward
  • Make sure that your strategy implements the most up-to-date guidances and standards. Stay up to date 
  • Get to know your testing laboratory and certifiers early in the design process to ensure no critical milestones are overlooked. Partner up
  • Compliance processes take a considerable amount of time. Early engagement gives you the best chance to meet deadlines. Get a head start

 

Listen to the full Podcast on Global Regulatory Trends –> Click Here

 

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 RegulatoryRegulatory 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. 

 

Artificial Intelligence in Medical Devices

Posted on by Brandon Miller

Measuring the impact of the FDA’s Regulation Proposal

 

With recent developments in technology, we have seen artificial intelligence and machine learning more commonly used across all aspects of our lives. Whether it’s our phones or smart speakers, this dynamic technology has applications in all industries, including the medical device industry. To ensure AI in medical devices can evolve while still protecting patient well-being and safety, the FDA recently released new information about its plan to regulate developments.

 

Looking to Implement AI into your Medical Device? Contact Us Now →

 

Artificial Intelligence vs. Machine Learning

 

Artificial intelligence and machine learning are two similar terms people commonly use interchangeably when discussing this type of software or technology, but they actually mean different things.

 

Artificial intelligence refers to any kind of technology deemed to be “intelligent,” or capable of understanding new data and adapting its functions accordingly. Machine learning refers — not to the device or software itself — but rather to the method scientists use to “teach” software to adapt to new information through learning and updating stages. Usually, machine learning is applied in the form of decision trees, where a certain action will always lead to a certain response and each action after follows a set path.

 

Researchers are now using machine learning to improve the efficiency of AI in medical devices. Practitioners often use different kinds of software to help them examine and treat patients, and AI as a part of medical device software is growing a little more every day. Machine learning allows AI devices to monitor patients, improve medical imaging software and even the potential to deliver certain treatments to patients.

 

However, AI doesn’t learn the same way humans do. AI software and algorithms are taught to adapt based on statistics and patterns they gather from experience. This capability means AI medical devices have the potential to develop very quickly as they receive and analyze risk management data in real-time and in real-life applications.

 

FDA Concerns About Artificial Intelligence in Medical Devices

 

There are two main types of technological algorithms:

 

  • Locked algorithms: only understand information and analyze it based on the way they were programmed. If you ask a locked algorithm a question or input certain data, it will always offer the same solution or result.
  • Adaptive algorithms: can respond and recognize new patterns or opportunities as it receives new data, and adjust it’s process or response accordingly.

 

Adaptive algorithms in medicine are currently causing the FDA the most concern. When companies that create software or medical devices give AI-based programs or products the freedom to examine or help treat patients by allowing them to respond to real-world situations and data, they have less control over what the AI learns and how it uses that information to adapt. If left unchecked or under-regulated, this could pose the possibility of changes developing that could create patient risk.

 

The FDA is currently working to develop a framework that will allow for the safe use of ever-adapting AI in the hospital setting. To make sure patients stay protected, FDA representatives have indicated that if an AI medical device is approved, it would have to be monitored constantly for changes in its algorithm. Making sure all the information the AI absorbs and analyzes stays transparent and malleable is crucial for maintaining a secure healthcare practice.

 

Challenges of Implementing AI Medical Devices

 

Another concern that artificial intelligence medical devices FDA regulations will address is helping AI respond better to individual patients. Unfortunately, there is no one-size-fits-all approach. Some illnesses or conditions may affect people differently.

 

This means some situations might confuse an AI machine or cause it to not analyze things properly. Researchers and the FDA must account for such gray areas and variables that could cause an AI device to malfunction or compromise the safety of patients. Programming an AI algorithm to understand cause and effect or to strategize using a decision tree can’t account for all potential factors.

 

The Future of AI in Medical Devices

 

The FDA is working to develop appropriate regulations for the use of Software as a Medical Device. Products that are driven by AI software or processes fall under this category, but given their unique ability to adapt to new data, they likely require separate scrutiny. As AI continues to evolve in the coming years, the FDA will have to keep a close watch on its applications and uses in the medical field to ensure patient protection.

 

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

 

artificial intelligenceRegulatory 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. 

 

IVDR & In Vitro Diagnostics

Posted on by Brandon Miller

In Vitro Diagnostics Regulation (IVDR) Changes

 

Listen to this In Vitro Diagnostics highlight from RCA Radio where Seyed Khorashahi breaks down the EU’s move from list-based IVD device classifications to a rule-based IVDR medical device classification, resulting in four new device classes.
 
 

 

Listen to the entire episode where we go over all of the important things happening in the Medical Device industry here.

 

 

Device Classification Changes

  • List-based Classification to a Rule-Based 
    • Class A (lowest risk) to class D (highest risk), where class B, C, and D would require Notified Body (NB) involvement.
  • MDGC 202- 16 Guidance on Classification for in vitro diagnostic Medical Devices under Regulation (EU) 2017/746.

 

Lifecycle Approach

  • Establishment and Demonstration of effective Quality Management Systems (QMS).
  • More stringent requirements for clinical evidence that demonstrates conformity.
  • Post-Market Performance monitoring and reporting requirements.
  • Introduction of Unique Device Identifiers (UDIs) for improved traceability.

 

Supply Chain Oversight

  • Regulations covering the entire supply chain.
    • Economic Operators
      • Importers
      • Distributors
      • Authorized Representatives
  • Notified Bodies have discretionary authority to audit suppliers and subcontractors

 

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

 

IVDR 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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