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Panel: Implementing Changes to ISO 14971:2019 to Comply with Global Regulations

Wil Vargas  (Director, Standards, AAMI)

Pat Baird  (Regulatory Specialist, Philips)

Edwin Bills  (Principal Consultant, Edwin Bills, Consultant)

Jos van Vroonhoven  (Senior Manager, Standardization, Philips, the Netherlands)

Location: 210D

Date: Wednesday, February 12

Time: 10:45 am - 11:45 am

Track: MD&M Conference: Understanding the Impact of Recent Changes to Quality Standards (in partnership with AAMI)

Vault Recording: TBD

The new edition of ISO 14971:2019, Medical devices – Application of risk management to medical devices, has new definitions and updated requirements, as well as three informative annexes. Come and hear from the experts about the details of the 2019 revision and how this will impact medtech companies. Topics covered include:

  • Why device manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall residual risk, and production and post-production activities
  • The importance of understanding how the new edition of the standard will influence your regulatory compliance with risk management requirements
  • Discussing strategies for implementing changes correctly

Presentation File