FDA Presentation Update on Part 11

John Murray FDA’s Device Center Part 11 expert gave an update on Part 11 electronic records and signatures at AdvaMed Medical Technology Software Conference that was held on November 8-9, 2006 . His slides are at the link provided and discuss the direction being considered for revising the regulation, narrowing scope, and reducing it prescriptive nature.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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