Episode Details

This is the audio-only version of RQM+ Live! #39, originally recorded 26 August, 2021.

The climb to MDR certification is well underway for device manufacturers. It's been quite an undertaking, but with careful planning, budgeting and execution, it has and will lead to continued successful commercialization of medical devices and IVD’s in the EU. However, achieving certification is just the beginning. Compared to the MDD and IVDD, it will be quite challenging keeping up with all the new requirements for post-market reporting and documentation updates that these trigger. And although many IVD manufacturers are just getting started on the journey to IVDR certification, given the sheer volume of new requirements, the earlier you to start preparing for the post-market phase the better.

With heftier regulatory files to maintain, highly detailed clinical evaluations and PMCF/PMPF plans, many new PMS reporting requirements, and expectations for much more coordinated review of and updates to regulatory, clinical, and risk documentation at a higher frequency than ever before, it's critical to start considering how all of this will be accomplished in the years ahead. Something like a "simple" design change may never have the word simple in front of it again when considering the impact of any product modification across functions and documentation.

In this show we'll talk about what life will look like for regulatory, clinical, quality and PMS functions as we enter MDR/IVDR sustaining mode, and continue to support getting new products to market. Please bring your questions for our experts… we're here to help!

The panel will include:

  • Amie Smirthwaite, Ph.D. - Global VP, Clinical Regulatory Services
  • Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
  • Jon Gimbel, Ph.D. - Executive Director, Regulatory and Quality Consulting Services

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