Under the MDR, PMCF activities will be mandated as part of medical device surveillance programs. These activities should ultimately ensure patient safety through continuous monitoring of certain medical devices. While conducting PMCF activities may appear costly and burdensome, this process can be streamlined and even automated through technology.

During this webinar, we presented a step-by-step approach to defining a successful PMCF plan and discussed different PMCF scenarios and design types. Featuring Derk Arts, MD, PhD, Founder and CEO of Castor, and Nadine Leistner, PhD, Chief Scientific Officer of MEC-ABC Medical Care and Product Development.

We illustrated the steps needed to put together a PMCF plan that will pass Notified Body scrutiny. We also showed how you can put technology to work to support you with a wide array of PMCF approaches. Specifically, we discussed the following topics:

  1. Analysis of existing clinical data (clinical evaluation and instruction for use)
  2. Performing claim analysis and PMCF parameter deduction
  3. Justification of parameter, sample size and selection bias
  4. Selecting a PMCF approach and enrollment strategy
  5. Selecting a platform that suits the approach

 

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