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ISO 14971 Reboot: The Risk Management Standard for Medical Devices


Mizar Shivananda (Manager I, Quality, Boston Scientific)

Location: 210D

Date: Tuesday, February 6

Time: 11:00am - 11:45am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Regulatory & Quality Update

Vault Recording: TBD

The ISO 14971 standard was developed to help medical device manufacturers identify hazards, estimate and evaluate risk, and develop, implement, and monitor the effectiveness of risk-control measures, and the latest reboot will help manufacturers continue on the quest for quality. This session will cover everything you need to know about the updated standard.

Topics to be covered include:

  • The status of this standard’s issues, revisions and timing
  • Ways to use the standard’s reboot to reduce risk in your company
  • Practical case examples of how to use ISO 14971 to comply