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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Learning From HAIs: Understanding Reprocessing Regulations, Validation & Human Factors

Published Date: May 6, 2015

This lecture provides an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the health care facility, and how to perform a validation for a reusable medical device for use in the health care facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.

  • Review of current events
  • Discuss human factors issues
  • Overview of US and EU regulatory requirements
  • Practical example of developing a validation testing strategy including implementation rationales and test choices

Register