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BIOMEDevice Boston 2019 Schedule Viewer

 

Welcome to the Biomed Boston & ESC Boston 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that 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.

Are You Ready for EU MDR/IVDR Device Certification & Recertification?

Laura Jeannel (Program Manager, EU MDR, DePuy Synthes Companies (Senior Consultant))

Location: 160A

Date: Thursday, May 16

Time: 8:30am - 9:15am

Track: BIOMEDevice Boston, Track A: Product Development

Vault Recording: TBD

By May 2020, medical device manufacturers active in Europe must be fully compliant with the new EU Medical Device Regulations. These significant changes are increasing the pressure on manufacturers to comply to keep products on the market. In this session, we'll discuss the current status of the EU MDR regulations and explore compliance challenges for the medtech industry through a holistic quality and regulatory approach.

Topics covered include:
  • An overview of the significant impacts medical device manufacturers could see in their current business
  • Identifying gaps in product families for MDR compliance
  • Performing product portfolio assessments and whether it is cost-effective to recertify
  • Understanding new requirements for design control procedures
  • A practical checklist and a suggested timeline will be provided for manufacturers



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