Quality & Risk
Verification & Validation(V&V)
In one line
Confirming design outputs meet inputs (V) and that devices meet user needs (V).
Definition
Verification confirms by examination that specified requirements have been fulfilled (did we build the device right?). Validation confirms that requirements for a specific intended use can be consistently fulfilled (did we build the right device?).
Verification is usually done through testing, inspection and analysis against design inputs, such as bench tests, software unit and integration tests, and electrical safety testing. Validation checks the finished device, or an equivalent, under actual or simulated use conditions with intended users, and includes software validation, human factors validation and, where needed, clinical evaluation. Both must be planned, use predefined acceptance criteria and be documented.
Why it matters
V&V plans, protocols, and reports are central artifacts in design controls and submissions. Software V&V follows IEC 62304.
Common pitfalls
- •A common pitfall is conflating verification and validation activities, leading to incomplete testing or a failure to address user needs effectively.
- •Another mistake is performing V&V too late in the design process, making it costly and difficult to implement necessary changes.
- •Failure to adequately document V&V activities can result in regulatory non-compliance during audits or submissions.
- •Not considering cybersecurity V&V throughout the product lifecycle can lead to vulnerabilities in connected MedTech devices.
- •Over-reliance on software simulations without sufficient hardware testing for embedded systems is a frequent pitfall in software V&V.
Sources
- MDIC Case for Quality · MDIC
- FDA - Quality Systems · FDA
- ISO 13485 Standard Page · ISO