Verification and Validation Definitions

The attached document provides a list of verification and validation related terms and definitions used by FDA. It is intended to provide in one place an educational aide to understanding the distinctions in the terms and their overlap to increase common understanding and hopefully minimize lengthy arguments over terminology and focus discussion on substance.

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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