A medical device company is implementing a new COTS antivirus solution in its manufacturing plant. All validated machines and instruments must be retested for interoperability with the new software…

System design documentation describes intended behavior but does not actively test or confirm interoperability after a change.

In regulated medical device manufacturing environments, all validated systems must be re-tested when software changes are introduced. UAT specifically verifies end-to-end interoperability and functional correctness from the user and instrument perspective, satisfying the revalidation requirement imposed by frameworks such as FDA 21 CFR Part 11 and IEC 62304 before returning systems to production use.

Peer review examines design or code artifacts and does not validate runtime interoperability between the antivirus software and instruments.

Static code analysis tests source code for defects and is not applicable to validating COTS binary software against existing instruments.

Change control documentation records and approves the change process but does not itself verify that software and instruments operate correctly together.