PMPF is one part of the performance evidence story.

You need to tell the full story, and RQM+ has the systems, templates, and expertise to do it.

  • PMPF Planning Process

    Our clinical and post-market surveillance team is led by Amie Smirthwaite, PhD, former BSI global head of clinical compliance and contributor to “MDCG 2020-7, Post-Market Clinical Follow-Up (PMCF) Plan Template, A guide for manufacturers and notified bodies, April 2020.” While the PMPF guidance is still in process, it is expected to be similar to the PMCF guidance. Our MDCG committee experience, former NB leaders, IVD SMEs, and experience with IVDR implementations globally, provide us with unrivaled knowledge and expertise to meet your needs.

    RQM+ develops PMPF plans that align with your performance evaluation reports (PERs) and strengthen areas of weakness in performance evidence. We also collaborate with you to develop plans that you can execute successfully.

  • Performance Evidence Matrix

    Every PMPF project starts with a performance evidence matrix that compiles and stratifies available data to ensure indications and claims are supported as required by IVDR. Subject matter experts and medical writers with clinical and regulatory expertise collaborate to generate the matrix. The result is a document that clearly identifies shortcomings in performance evidence so you know what gaps need to be addressed. 

  • PMPF Pathways

    All IVD manufacturers have different business goals and a mix of products to support them. Because there is no one-size-fits-all solution to PMPF planning and execution, RQM+ will identify multiple options and help you select the one that makes the most sense for your business priorities based on the associated risks. 

    Learn more about the RQM+ approach.

  • PMPF Plan Drafting

    With PMPF being new to many IVD companies, you may not have the in-house resources yet to get the work done. Our dedicated team will draft plans based on the performance evidence matrix and defined strategy and ensure that it aligns with other PMS activities.

    In addition to providing an evaluation of the performance data for similar devices, guidance on methods, and rationale for the appropriateness of those methods, we will also reference the relevant parts of the PER and the risk management file to paint a complete picture for your notified body.

  • PMPF Plan Implementation

    Writing a plan is just the beginning. You must also execute the plan and write reports that demonstrate your protocols are being followed. The expert implementers at RQM+ provide support by creating efficient systems and processes to keep the required resources and associated costs at a minimum without compromising on quality.

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    Procedures

    PMPF is new to many diagnostics manufacturers, which means new resources and additional costs. Let RQM+ experts implement procedures based upon best practices to optimize your resources and ensure implementation before your certification audit.

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    Protocols

    Without protocols that are realistic and easy to follow, you’re setting yourself up to fail. Processes that are too cumbersome get abandoned, which means you fall out of compliance. RQM+ knows how to balance notified body expectations with the practical realities of execution.

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    Report Writing

    IVDR requirements include generating reports that evaluate the execution of your PMPF plans. This documentation must also align with other PMS and performance evaluation activities. RQM+ understands the big picture and knows how to effectively communicate it to notified bodies.

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    Report Maintenance

    PMPF is a continuous process that requires ongoing planning and reporting as new information becomes available. RQM+ can create and maintain a reporting schedule so your team can focus on daily operations without worrying about PMPF compliance.

     

    PMPF is just one page in the PMS story.

    The best way to tackle any component of post-market surveillance is to do it with the whole story in mind because this is how notified bodies approach it. If your documents don’t align, it leads to reviewer questions and a longer approval process. Our integrated approach ensures your PMS activities and documentation always align.

    Learn about Post-Market Clinical Follow-up

    Learn about Quality System Integration

    Learn about PMCF Survey Development and Execution

    Post-Market Clinical Follow-up (PMCF) 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.

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

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