Category: Medical Device

The FDA recently issued the Final Rule for the Quality Management System Regulation (QMSR) that amends the current medical device cGMP requirements of the Quality System (QS) regulation (21 CFR 820).

 

The FDA over the last few years has been looking to harmonize its medical device CGMP regulatory compliance and this action continues its efforts to align with other regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices for patients.

 

Effective February 2, 2026, two years after the publication of the final rule, FDA will begin to enforce the QMSR requirements upon the effective date. Until then, manufacturers are required to comply with the QS regulation.

 

What is Changing?

Title: The new rule amends the title of the regulation. The revised part 820 will be referred to as the Quality Management System Regulation (QMSR).

 

Requirements: 21 CFR 820 has been amended by incorporating the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes. The FDA implemented this final ruling to promote consistency in the regulation of medical devices.

 

Additionally, the rule establishes more requirements that clarify certain expectations and certain concepts used in ISO 13485 to mitigate inconsistencies with other applicable FDA requirements. FDA has also made conforming edits to part 4 (21 CFR part 4) to clarify the device Quality Management System (QMS) requirements for combination products.  These edits do not impact the CGMP requirements for combination products.

FDA’s FAQ’s

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves 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 new product launch. 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 consultant 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 medical device consulting companies have the same regulatory compliance expertise when introducing a new product 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 launch planning.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical device 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 release product.

 

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 medical device regulatory 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 that increase medical device regulatory success.

 

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 product launch events associated with product launch and new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the product launch strategy approval process and post-approval support. 

 

  • New Product Releases
  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

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 a product launch, 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 consultants & FDA, MHRA & EMA veterans are industry professionals offer a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex medical device regulatory challenges within medical device consulting companies.

 

  • Compliance Enforcement
  • Product Release Strategy
  • New Product Launch Strategy
  • Product Launch Steps
  • Medical Device cGMP
  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

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 product launch. 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 medical device consultant assistance 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.

 

  • Product Launch Planning
  • Product Launch Roadmap
  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • IVDR & IVD 
  • Medical Device cGMP
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation 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.

 

Our value starts before the product launch 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
  • Medical Device 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 launch and total 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 successful product results to your business — no matter your size or unique needs.

 

  • Launch Strategy
  • Product Launch Process
  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • 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. 

 

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 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 new product launch. 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 consultant 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 medical device consulting companies have the same regulatory compliance expertise when introducing a new product 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 launch planning.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical device 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 release product.

 

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 medical device regulatory 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 that increase medical device regulatory success.

 

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 product launch events associated with product launch and new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the product launch strategy approval process and post-approval support. 

 

  • New Product Releases
  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

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 a product launch, 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 consultants & FDA, MHRA & EMA veterans are industry professionals offer a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex medical device regulatory challenges within medical device consulting companies.

 

  • Compliance Enforcement
  • Product Release Strategy
  • New Product Launch Strategy
  • Product Launch Steps
  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

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 product launch. 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 medical device consultant assistance 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.

 

  • Product Launch Planning
  • Product Launch Roadmap
  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation 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.

 

Our value starts before the product launch 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 launch and total 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 successful product results to your business — no matter your size or unique needs.

 

  • Launch Strategy
  • Product Launch Process
  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • 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. 

 

 

 

In this soundbite from RCA Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through before they receive regulatory approval.

biocompatibility

 

This biocompatibility risk-based approach evaluates the risk of the device through consideration of the device’s cytotoxicity, irritation, and sensitization. 

  • Cytotoxicity – Will the device kill or harm the cells it comes in contact with?
  • Irritation – Will the device make contact with the patient and cause skin irritation? (Redness and/or Swelling)
  • Sensitization – Will the device cause an allergic reaction?

Listen to the full episode “Intro to Pre-Clinical Testing and Biocompatibility” now!


 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves 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 consultant Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work directly with your company.  Our biocompatibility consultants will 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 medical device consulting companies 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 medical device regulatory 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 biocompatibility & 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
  • EU IVDR

 

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 consultants & FDA, MHRA & EMA veterans are industry professionals offer a unique blend of biocompatibility expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Compliance Enforcement
  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

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 biocompatibility 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 medical device consultant assistance you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years of 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

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges has 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.

 

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
  • 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 5,000 customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

 

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. 

 

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.

Since the Pandemic became global in 2020, the FDA has been requesting documents from firms in advance of or in lieu of an inspection. This authority comes from the Federal Food, Drug, and Cosmetic Act (FD&C Act) in Section 704(a)(4). However, while they have not adopted doing FDA remote inspections in place of an onsite inspection, they have stated publicly they are considering the possibility and virtual audits have become very common. 

 

FDA is still conducting onsite inspections and has submitted for new employee headcount in 2022 to reduce the existing backlog. Each inspection is carefully considered on a case-by-case basis where there is an imminent public health need. Factors such as risk to the FDA investigator and site personnel are also considered when determining if a virtual audit is appropriate.

 

Onsite inspections could be the standard inspection with the investigators staying in the facility the entire time or it could be a hybrid approach where the investigators spend some time in the facility and other time doing remote FDA reviews and conducting video interviews.

 

2022 will bring a new wave of inspections to the medical device and pharmaceutical industry. So how can you prepare in advance? And what does good look like from a virtual inspection process? Below are some thoughts for your team to consider.


Ready to Conduct a Mock Virtual Audit? Contact Us Now →


How Would a Virtual Inspection Work?

Virtual health authority inspection is accelerating as the Pandemic continues. FDA registrations simply don’t end and some health authorities outside the US have already done remote inspections already (e.g. the EMA). However, while the FDA has not done a true remote inspection, they have done many hybrid inspections.

 

What does the hybrid approach mean?

 

It is part of onsite work and part offsite/remote work. With the hybrid FDA format, the FDA uses tools like video chat for activities like virtual interviews. They also use technology like secure shared online folders for offsite document review. Companies prepared to manage FDA inspections under this new method stand the best chance of success in an inspection.

 

The FDA could start with a records request and then come onsite, or vice versa. Remember, if it is a true inspection the FDA must provide the most senior ranking person at the site a Notice of Inspection, Form FDA 482, at the very start of the inspection. If the Form 482 isn’t issued, then it is likely a records request utilizing their Section 704(a)(4) authorities.

 

FDA virtual inspection

 

FDA record requests should follow the process and guidance outlined in their internal Staff Manual Guide, SMG 9004.1 Policy and Procedures for Requesting Records In Advance of or In Lieu of a Drug Inspection. Think of the SMG as an internal procedure for the FDA. If you are curious you can find it at this link: Staff Manual Guide 9004.1 (fda.gov)

 

 

Bottom line, if the FDA’s request comes through a call or email then it is not an inspection. It is a records request and should follow the procedures in SMG 9004.1. If they show up onsite, present a Form 482, then it is an inspection. Then the inspection could stay all onsite or it could be a hybrid approach, as noted above.  

 

Planning for an FDA Virtual Inspection

With the current pandemic, FDA has been providing a little advanced notice of the inspection, usually a few days to a week. The notice is directed less at giving companies time to prepare and instead intended to ensure the required personnel, who may be working offsite, are available. But prior planning precludes poor performance, so prepare well beforehand to manage a hybrid virtual inspection.

 

Some recommendations for inspection prep and readiness are as follows:

  • Determine who in the company will host the FDA inspection. Whether it’s onsite or virtual or hybrid you’ll want to designate a host. This distinction lets you train someone for the role, which helps streamline the process and eliminates last-minute challenges
  • Who will be the scribe and how will they take notes and communicate with the site team?
  • Determine who will step in as the back-up host and scribe in case the primaries are out sick.
  • Think through how the FDA inspection will flow, from the time it starts, through the facility tour, document requests and employee interviews.
  • If a virtual walk-through is conducted do you have sufficient Wi-Fi capabilities across the entire facility to avoid glitches in the audit and video.
  • How will you do the video? Use a phone camera or a real video camera.
  • Make sure you have the equipment ready to go and have tested it throughout the site.
  • How do you plan to maintain appropriate social distancing? Some companies have set up conference rooms complete with plexiglass barriers, tape markers on the floor and separated seating. In other cases, some activities are conducted outdoors, weather permitting.

 

Some additional helpful tips based on our experience with other clients are:

  • Collecting documents: This one can take a little time and it’s suggested that you start with the basics that you know the investigator will request, for example, a general site presentation, a batch record, deviation list, complaint list, facility layout, CAPA list, compliance documents, change controls and other master files.
  • Scanning and saving: Scan these documents ahead of time and upload them to an online company drive that is easily accessed by the inspection team.
  • Getting the right equipment: Whether you plan to use a smartphone or Wi-Fi camera, make sure the user knows how to operate it correctly and it works in every nook and cranny of your facility.
  • Running simulated inspections: A walkthrough lets you test video and audio quality. You can also identify and address poor Wi-Fi connectivity.

 

Virtual and hybrid inspections are a new format, and there can be challenges on both sides. Make sure your plan has some flexibility. Also, keep an eye on the FDA’s website for any announcements on virtual inspections. If the FDA does decide to start conducting virtual inspections it is likely that they will also roll out internal processes and procedures to ensure a harmonized approach. These items could be a Staff Manual Guide or a new chapter in their Investigations Operations Manual (Investigations Operations Manual | FDA).

 

About RCA

 

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, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and 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, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • 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 expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our 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 pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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.

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

 

Remediation 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

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

 

About RCA®

 

Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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. Our life science consultants 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
  • 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.

 

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. 

 

 

One of the most crucial parts of running a business in the pharmaceutical or medical device industry is meeting the standards that will ensure your customers receive the highest-quality service. That’s why many businesses today choose to outsource certain functions of their post market surveillance activities.


Let us help you Outsource your Post Market Surveillance Activities. Contact Us Now →


Outsourcing is a business strategy that only began to surface in the 1980s and 1990s. Since then, it has become a powerful value proposition for industries everywhere. In the 2000s, businesses within the life sciences industry started implementing the practice. Now, the outsourcing of external resources for compliance needs is a common strategy for companies looking to expand their reach and climb the industry ladder.

 

Why Are Certain Functions Targeted for Outsourcing?

Companies may choose to outsource any number of activities to improve business operations, but there are a few specific types of functions that leaders tend to target for outsourcing. For example, companies often outsource lower risk activities that include higher volume but lower-complexity tasks.

 

The reason for this is that there are many expert consultants needed for complicated specialties that businesses are responsible for. However, when leadership removes the tedious or time-consuming tasks, such as data management, they may increase the team’s ability to focus on the larger picture or invest in business ventures.

 

Outsourcing low-risk tasks lifts a significant burden from the shoulders of leaders and employees while allowing them to focus on the creative, strategic and higher-risk parts of the business instead.

 

Why Outsource Post Market Surveillance Needs?

The reason so many businesses choose to outsource rather than use internal resources is the challenge of the recruiting process. Companies often find that understanding regulations, compliance, hearing the Voice of the Customer and managing regulators is an important core competency / knowledge that balances other internal functions and decision making. Thanks to ever-changing standards and laws in the medical device and pharmaceutical industries, very few companies have the in-house resources to keep these standards up-to-date.

 

Managing post market surveillance activities may be outside the realm of your team’s skill set and understanding, but outsourcing allows you to work with experts in the field. While compliance issues can hold your company back, having an experienced partner at your side ensures that all of your compliance needs will be in order.

 

Some of the long-term benefits of outsourcing post market surveillance activities include:

  • High-efficiency value proposition: With the help of an healthcare consulting firm, you can more quickly and effectively serve your customers. Over a long-term basis, this will help you both retain customers and attract new ones.
  • Lower functional costs: Reducing operational costs so you can increase profits and grow as a business is one of your main goals. Thanks to the benefit of a more efficient work environment, you will save capital for opportunities like mergers and acquisitions.
  • Refocus talent and skill: Free up your high cost internal resources to allow them to focus on critical work and decisions which you can then leverage for the benefit of your business by outsourcing low-risk tasks. Refocus your most valuable members and resources on their greatest strengths while leaving the rest to external experts.

 

Outsourcing your post market surveillance activities is an area that continues to grow worldwide. With the help of a third party, you can keep everyone in your business assigned to the tasks that allow them to best use their core competencies and create a more productive work environment.

 

About RCA®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the 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.

 

 

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. 

 

 

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®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the 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.

 

 

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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