University of Minnesota
Software Engineering Center

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Medical device safety assurance cases: Using what we already do

Regulations for medical devices around the world require that risk analysis and management be conducted prior to a device being approved for sale. Most medical device manufacturers use the process described in the ISO 14971 standard for medical device risk management to do this risk management. How can we use the work that is already being done and the artifacts already being created to produce a safety assurance case? This tutorial will focus on what can be used from the risk management file required by ISO 14971 and what needs to be added to produce a compelling safety assurance case.

This tutorial is offered in the afternoon of Friday, July 29.