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Key Aspects of Usability Testing of Medical Devices to Increase Approval Success and Reduce Costs

Beth Loring  (Founder & Principal, Loring Human Factors, LLC)

Location: Biomed Room 1

Date: Thursday, September 17

Time: 2:00pm - 2:45pm

Track: Track C: Surviving the Changing Regulatory Environment & Rising Costs

Vault Recording: TBD

The FDA and international regulatory bodies require usability testing of medical devices, software, and combination products during development and as part of validation. Manufacturers must demonstrate that all use-related hazards have been identified, prioritized, and mitigated. This is done by following a comprehensive human factors/usability engineering (HF/UE) process ending with validation (a.k.a. 'summative') testing. This presentation will discuss ways in which the appropriate application of HF/UE can increase approval success and reduce overall development cost and business risk.

Topics include:

  • What a successful HF/UE process looks like and why it is required for regulatory approval
  • Discuss what FDA reviewers expect to see at the end of the process
  • Get answers to their specific medical device usability testing questions and challenges