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.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.