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Workshop: Connecting the Dots to Better Manage Your Risk: ISO TR 24971

Edwin Bills  (Principal Consultant, Edwin Bills, Consultant)

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

Pat Baird  (Regulatory Specialist, Philips)

Location: 210D

Date: Wednesday, February 12

Time: 1:15 pm - 3:00 pm

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

Vault Recording: TBD

Technical report ISO/TR 24971, Medical devices – Guidance on the application of ISO 14971, has been revised in parallel with the standard ISO 14971:2019, Medical devices – Application of risk management to medical devices. Several informative annexes of ISO 14971:2007 are moved to this report, revised and supplemented with additional guidance. The structure of the report follows the same numbering as the clauses of the standard, with specific guidance on dedicated topics in its annexes. Join this interactive workshop to understand the guidance to be fully compliant with the requirements of ISO 14971:2019. Topics covered include:

  • Setting the policy for establishing the criteria for risk acceptability
  • Evaluating the overall residual risk
  • Production and post-production activities
  • Remediating the risk management file for devices designed without ISO 14971