FDA Inspection Issue Terminology

FDA issues Field Management Directives on a number of subjects including #120 483s and #86Estabilishment Inspection Report Conclusions and Decisions. The latter is at the link provided and includes tables definings FDA’s terminology for rating inspectional issues and conclusion.

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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