Design Verification
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Design verification confirms, through objective evidence, that design outputs meet the specified design input requirements. It answers the question “did we build the device right?” by testing, inspecting, analyzing, or otherwise demonstrating that each output — a drawing, a specification, a piece of software — satisfies the requirement it was derived from, before design validation is attempted.
Verification is a requirements-matching exercise, not a use-context exercise. A typical verification activity confirms a mechanical tolerance was met, a material passed a biocompatibility test to the specified standard, or a software module returned the expected output for a defined input set — each traced back to a specific, numbered design input.
Because verification is where most design-control traceability lives, it is usually organized around a requirements traceability matrix linking every input to at least one verification method and result. Design changes made after verification is complete require re-verification of any input the change could affect, which is where change-control discipline and design controls intersect.
- —Confirms design outputs meet design inputs — “built the device right”
- —Precedes design validation, which asks whether the right device was built
- —Organized around a requirements traceability matrix
- —A design change triggers re-verification of any affected input
21 CFR 820.30(f) (pre-QMSR) / FDA QMSR (2026); ISO 13485:2016 §7.3.6; EU MDR 2017/745 Annex I
Frequently asked questions
What is Design Verification?
Design verification confirms, through objective evidence, that design outputs meet the specified design input requirements. It answers the question “did we build the device right?” by testing, inspecting, analyzing, or otherwise demonstrating that each output — a drawing, a specification, a piece of software — satisfies the requirement it was derived from, before design validation is attempted.
Which regulations cover Design Verification?
21 CFR 820.30(f) (pre-QMSR) / FDA QMSR (2026); ISO 13485:2016 §7.3.6; EU MDR 2017/745 Annex I