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Panel: Strategies for Implementing the New EU MDR Requirements

Marcelo Trevino (Global Vice President, Regulatory Affairs & Quality Assurance, Agendia)

Vinay Goyal (Principal Consultant/Project Manager, Consultant)

Jim Talbot (Vice President, RA/QA, Zap Surgical)

Anthony Rizzo (Assistant Vice President Healthcare Development, BSI Medical Devices)

Kim Trautman (Executive Vice President, Medical Device International Services, NSF International)

Kerri Casino (Senior Manager, Regulatory Affairs, Edwards LifeSciences)

Location: 210D

Date: Tuesday, February 11

Time: 10:45am - 11:45am

Track: MD&M Conference: Keeping Up & Staying Compliant with Global & FDA Regulations

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 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 covered include:

  • Key elements of the Periodic Safety Update Report (PSUR) important to your risk management plan
  • Discuss important aspects of the Summary of Safety & Clinical Performance (SSCP)
  • Review the status of the European Database on Medical Devices (EUDAMED)
  • What parts/products are impacted with Restricted Substances
  • Sharing of lessons learned and discussion of current challenges