Verification and Validation

Verification and Validation (V&V) is the umbrella process that proves a design was built right (verification — meets the specification) and was the right thing to build (validation — meets the user/customer/intended-use need). It is the right leg of the V-model, the heart of FDA 21 CFR 820.30, ISO 13485 §7.3, IEC 62304, and AS9100D, and the gating discipline before any of Release, NPI, or Regulatory Submission.

Scope

• V&V planning — test plans, V&V matrix, sample sizes, acceptance criteria, environment specs.
• Verification activities — inspections, analyses, demonstrations, tests against requirements (DR/DRR design reviews, FEA correlation, hardware-in-the-loop, SIL/MIL/HIL).
• Validation activities — clinical/usability evaluation, customer trials, simulated-use studies, field beta.
• Trace closure — every requirement closed by ≥1 verification or validation evidence; gap reports drive scope.
• Anomaly handling — bug triage, deviation requests, retest planning, sign-off authority.

Relationships (see sidebar)

• Realizes Product Quality, Regulatory Compliance, Cybersecurity by Design, and First Time Right.
• Supported by Requirements Traceability, CAD Simulation, FEA, CFD, Tolerance Analysis, ALM Traceability, and FMEA.
• Distinct from Prototyping & Validation which is the build event; V&V is the broader test discipline that runs across virtual and physical builds.