Verification & Validation (V&V)
Verification & Validation (V&V)
Demonstrating Product Quality Through Structured Verification and Validation Strategies
Verification and validation are essential components of a controlled product development process.
Verification demonstrates that specified requirements have been fulfilled, while validation provides evidence that the product is suitable for its intended use and meets the needs of its intended users.
Avary Consulting supports companies in planning, coordinating, and evaluating appropriate V&V activities.
We consider applicable requirements under the MDR, IVDR, ISO 13485, and, where relevant, the FDA QMSR, together with product-specific technical standards.
Our services include:
- Development of risk-based verification and validation strategies
- Support for V&V plans, test protocols, and reports
- Definition of clear and traceable acceptance criteria
- Development and evaluation of traceability concepts
- Coordination of internal and external testing activities
- Assessment of deviations and required retesting
- Support for statistical testing and sampling strategies
Our Recommendation for Manufacturers: Establish clear traceability between design inputs, risks, test methods, acceptance criteria, and results at an early stage. Consistent traceability facilitates technical assessments and regulatory submissions.