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PMCF plans, activities, and reports are key parts of post-market surveillance (PMS) necessities for medical devices in the EU under MDR. As a component of our thorough PMS services, Graywolf Research Group offers expert support for PMCF activities to guarantee the performance and safety of your device.
Graywolf Research Group creates PMCF plans, overviews, and reports that line up with your CERs and reinforce weak spots in clinical evidence. Similarly significant, we work with you to foster plans that you can execute effectively.
While fostering a PMCF plan, it is essential to understand what information you should take. Our clinical evidence matrix features weaknesses and gaps so we can assist with working on a strategy for telling the entire clinical story.
We will assist with adjusting your internal teams and set up timelines and systems of events to tell the complete story of adequate clinical proof.
Whether for specific projects or all things regulatory, add capacity to your internal team for assigned product lines with our subject matter expert support.
