Verification & Validation for Medical Devices
Verifying and validating the performance and safety of medical devices is crucial, confirming that device functionalities work as intended under real-world conditions
Our QA/RA consultants provide guidance on conducting appropriate verification and validation activities, including such as design verification and software validation.
Robust verification and validation (V&V) processes are fundamental to ensure that medical devices not only meet their specified design requirements but also perform reliably in the context of their intended use.
Verification
This step verifies that “you built the device right.”
Validation
Validation ensures that “you built the right device.”
Verification and Validation plan
A comprehensive V&V plan addresses not only the core device, but also software components, integration with other systems, and compatibility with accessories or consumables. It incorporates risk-based approaches to determine the depth and breadth of testing required, ensuring that critical safety and performance features are thoroughly assessed. All protocols and results are meticulously documented, providing objective evidence that the device is both safe and effective.
Equally important is the traceability between requirements, verification methods, and validation outcomes—ensuring that every claim and regulatory expectation is backed by tangible, reproducible data. This rigorous approach supports regulatory submissions, facilitates faster approvals, and instills confidence in healthcare providers and patients alike.
By adopting best practices in verification and validation, manufacturers not only achieve compliance but also proactively safeguard product quality and patient safety throughout the device’s lifecycle.