V&V testing confirms your device meets safety, performance, and risk requirements through sterility, biocompatibility, electrical safety, performance, and software validation. Comprehensive, standards-based testing helps avoid FDA review delays.
Verification and validation (V&V) testing demonstrate that your device meets design specifications and user needs and that it is as safe and effective as the predicate. Testing requirements are risk‑based and depend on the device’s intended use, contact duration and technological characteristics. A robust V&V plan typically encompasses the following categories:
Devices supplied sterile must validate the sterilization process (e.g., gamma, ethylene oxide) and demonstrate that packaging maintains sterility over the claimed shelf life. Standards such as ISO 11737‑2 (sterility tests) and ISO 10993‑7 (ethylene oxide residuals) are commonly used. Packaging validation relies on ISO 11607‑1/‑2 and ASTM F1980 for accelerated aging. Include both accelerated and real‑time aging data; accelerated aging alone is insufficient.
Shelf‑life studies assess the stability of device materials and packaging under storage conditions. Real‑time aging data correlate with accelerated aging to substantiate expiration dates. Include worst‑case packaging configurations, and justify shelf life with data rather than assumptions.
For devices that contact the body, evaluate potential biological risks according to the ISO 10993 series. Chemical characterization (ISO 10993‑18), cytotoxicity (ISO 10993‑5), sensitization (ISO 10993‑10) and irritation (ISO 10993‑23) are typical tests. The FDA’s guidance clarifies that biocompatibility information is unnecessary only if the device has no direct or indirect tissue contact. Evaluate the finished, sterilized device in its final packaging and specify the device’s contact duration and tissue type.
Devices powered by electricity must comply with standards such as IEC 60601‑1 (general safety), IEC 60601‑1‑2 (EMC) and IEC 61010‑1 (laboratory equipment). Electrical safety testing addresses risks of shock, fire and malfunction. The FDA frequently cites electrical safety failures; more than 90 percent of devices tested fail on first submission. Plan sufficient time for electrical testing and address any identified hazards.
Bench testing assesses mechanical properties (e.g., tensile strength, fatigue, wear), device accuracy and software functionality. Human factors validation and usability testing demonstrate safe and effective use by the intended user population. If bench data cannot demonstrate equivalence, clinical studies may be necessary. Provide complete protocols, acceptance criteria and results; incomplete testing is a common cause of 510(k) rejection.
ISO 14971 requires identifying hazards, estimating risks and implementing controls. Document your risk analysis and show how hazards are mitigated through design controls, testing and labeling. Connect each hazard to specific V&V activities and include residual risk assessments.
Developing an integrated V&V plan early in the product development cycle ensures that data collection aligns with the substantial equivalence argument and reduces surprises during review. Engage subject matter experts for complex testing (e.g., electrical safety or biocompatibility) and incorporate their recommendations into your submission.
