FDA Interoperability Final & Cybersecurity Revision

At the AAMI/FDA Software Regulatory Class being held this week, it was stated that the following are expected to be released this summer by FDA:

– Revision to the premarket cybersecurity guidance
– Final of the interoperability guidance

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.

Leave a message and we will contact you to schedule:

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