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
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: