FDA to issue new draft Part 11 guidance

FDA is about to issue a draft guidance on maintenance of electronic records (e.g., archiving). The pre-publication notice is at the link provided.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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