FDA CDRH CADx Workshop Summary

On June 26, 1996 FDA held an open public workshop a on computer-aided diagnosis and medical devices as a step in developing further policy and guidances for such devices/software. Summaries of the presentations and participant comments are provided in this text.

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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