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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 and Attain Compliance

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

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

Location: 160A

Date: Thursday, May 7

Time: 9:30am - 10:15am

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 an industry expert about ways to develop an implementation strategy. You'll also walk away with tips for updating your quality system processes and for managing critical changes. Topics will include:

  • Key elements of the Periodic Safety Update Report (PSUR) important to your risk management plan
  • What parts/products are impacted with Restricted Substances
  • Sharing of lessons learned and discussion of current challenges
  • New vs legacy product compliance