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BIOMEDigital 2020 Session Viewer

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The Race for Implementing the New EU MDR Requirements to Attain Compliance

Christopher Mauch  (Manager, Healthcare & Life Sciences, KPMG)

Rajesh Misra  (Principal - Life Sciences, Operations, KPMG)

Location: Center Stage

Date: Thursday, November 5

Time: 3:00 pm - 4:00 pm

Track: Center Stage

Vault Recording: TBD

Getting your device approved and through the new EU MDR regulatory requirements will be challenging, especially given the short time constraints, and the political EU environment. In this session, you'll hear from industry experts about keys to addressing top concerns as you develop an implementation strategy, particularly now that a one-year delay is in the works. You'll also walk away with tips for updating your quality system processes and for managing critical changes.

Topics include:

  • Important requirements for new vs legacy product compliance
  • What parts/products are impacted by restricted substances
  • Key elements and conclusions to include in a Periodic Safety Update Report (PSUR) important to risk-benefit determination for higher risk devices
  • Sharing of examples and lessons learned

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