PMCF is just part of the clinical evidence story.

We’ll help align your internal teams and put systems and timelines in place to tell the complete story of sufficient clinical evidence.

  • Business-Balanced Approach

    Our clinical team is led by Amie Smirthwaite, PhD, former BSI global head of clinical compliance and a contributor to “MDCG 2020-7, Post-market clinical follow-up (PMCF) Plan Template, A guide for manufacturers and notified bodies, April 2020.” Our collective knowledge gained from feedback from various notified bodies on PMCF plans and CERs gives us unique insights into what they expect to see.

    RQM+ develops PMCF plans, retroactive PMCF studies, and reports that align with your CERs and strengthen areas of weakness in clinical evidence. Equally important, we work with you to develop plans that you can execute successfully.

  • Clinical Evidence Matrix

    The RQM+ process starts with compiling a clinical evidence matrix that stratifies available data to ensure indications and claims are supported by sufficient clinical evidence. The matrix is created by a team of subject matter experts with a unique combination of clinical and regulatory expertise that you won’t see in other consulting firms. The clinical evidence matrix is completed with proposed PMCF approaches, based upon both device and regulatory risks, to fulfill all identified data needs.

    The result is a clear picture of regulatory risks at the product claims level, enabling discussions about business risk and possible pathways.

  • PMCF Pathways

    We know that every business and every product is unique, which is why we identify multiple PMCF approaches based on both device and regulatory risks. As a strategic partner that understands your business, we’ll provide options based on your objectives and help you decide on the strategy that makes the most sense for each of your product lines.

  • PMCF Plan Drafting

    Even if you have experienced medical writers on your team, they don’t always have the bandwidth to handle all of your needs across all product lines. We’ll provide a dedicated team to draft plans based on the clinical evidence matrix and defined strategy.

    The RQM+ team has the experience and expertise to provide an evaluation of the clinical data for similar devices, guidance on methods, and rationale for the appropriateness of those methods. When drafting plans, we reference the relevant parts of the clinical evaluation report and the risk management file to tie it all together for your notified body.

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    Protocols

    The first step is to create protocols that are realistic and easy to follow. When processes are too cumbersome, they get abandoned and you fall out of compliance. Our team understands how to balance what notified bodies want to see and what is practical for your team.
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    Retrospective PMCF Studies

    Developing and executing retrospective PMCF studies—a process that is new to many manufacturers—demands expertise and systems that you might not have in-house. Let us handle all of it for you.

    Learn more about retroactive PMCF studies
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    Report Writing

    MDR requires you to generate reports that evaluate the execution of your PMCF plans. These reports must also align with other PMS and clinical activities so they cannot be written in a vacuum. RQM+ understands the full picture and knows how to convey your story to notified bodies.
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    Report Maintenance

    Reports must be continually updated as new information comes in, and in some cases, they must be submitted on an annual basis. Let RQM+ create a maintenance schedule and do the work so your team can focus on daily operations without worrying about PMCF compliance. 

     

    PMCF is just one piece of the PMS puzzle.

    The best way to approach any element of post-market surveillance is to do it with the full picture in mind. Notified bodies expect to see a cohesive story, and if your documents don’t align, it creates more work in the long run. RQM+ takes an integrated approach that ensures your PMS activities and documentation are always in alignment.

    Learn about Quality System Integration

    Learn about retrospective PMCF studies

    Post-Market Clinical Follow-up FAQs

    Can we use PMCF to fill current clinical evidence gaps?

    In short, no because that is not the purpose of PMCF because you need to demonstrate conformity. Often, you do have gaps in your clinical data. You might have a lot of data on one indication and less on another one, but you can’t pose it as a gap and that you don’t have sufficient clinical evidence to demonstrate safety and performance for that indication.

     

     

    What are examples of inadequate PMCF data resulting in audit findings in MDD or MDR audits?

    We have seen the gamut from lower risk to higher risk devices needing PMCF. For example, we had a pretty well-established Class IIa device that had limited clinical data that was not high quality. They used equivalence and then got a finding asking them to prove they had sufficient clinical evidence for initial conformity based on the studies they did have.

     

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