FDA ADVAMED Part 11 Guidance Presentation

On 10/23/03 Joe Famulare leader of FDA’s Part Redirection committee gave a talk on the final guidance at an Advamed conference. A copy of his slides are 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.

office@softwarecpr.com

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