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Welcome to the Biomedevice Boston Presentation Store. Here you can view and download conference presentations before, during, and after the event, as well as free content from the Center Stage. If you’re looking for a presentation from a specific session, go to that session, and if we have the presentation to share, you’ll see the file below the session description. If you are unable to find it here, it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

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

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

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

Location: Biomed Room 1

Date: Thursday, September 17

Time: 8:30 am - 9:15 am

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

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