Design verification versus design validation

Design verification checks that design outputs meet design inputs. Design validation checks that the device meets user needs and the intended use.

ISO 13485 clause 7.3.6 describes verification. Typical evidence is a test, inspection, calculation or comparison against an input requirement: the tensile strength meets the number in the specification. Clause 7.3.7 describes validation, performed on representative product, under defined operating conditions, and completed before release for use. Clinical evaluation is often part of validation for a medical device. Usability validation is another common piece.

The short memory aid is still right: verification asks 'did we build the thing right?' and validation asks 'did we build the right thing?'. They are not interchangeable, and a bench test does not become validation because the title slide says so.

HAVGATE's audit checklist can sample a completed design project under MDSAP Chapter 5. It does not store a requirements trace matrix as a published design-control product.