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Update on ISO14971 Direct from AAMI

Mark Swanson (Principal Consultant, H&M Consulting Group, LLC)

Location: 210D

Date: Wednesday, February 6

Time: 10:15am - 11:00am

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

After much discussion, it was decided that the international standard ISO 14971:2007 would be revised by
AAMI and FDA. It is expected that the revised international standard will be adopted as a European Standard, and changes will be implemented in the first or second quarter of 2019.

Topics covered include:
  • Exploring the impacts of the revisions and the impacts on medical device manufacturers
  • What should device makers remediate and change in their quality systems?
  • How does this impact risk management