The two “Vs” — also known as V&V, verification and validation — serve to link the medical device product that has been developed all the way back to the initial customer needs and product requirements.
Bill Betten, Betten Systems SolutionsWhile many think that verification and validation only occur at the end of the medical device development effort, that is only partially true. Yes, V&V take place after some portion of the product has been built and is available to be tested. But the planning for these two tasks is critical. Definition of the tests to be performed and plans for that testing need to take place early in the development process.
In fact, the V&V process ties the results back to the initial requirements, but the results also form the basis for a subsequent successful submission to the FDA (or other regulatory body). Verification and validation have a direct influence on the success of your product development effort.
As a reminder, this is the fifth and final article in a series focusing on the definition and execution of product development activities post-funding. It includes the following:
- Idea – Without it, nothing to be developed
- Process – The structure for development
- Plan – The blueprint
- Requirements – The details
- Regulatory / Reimbursement – Critical to the medical device space
- Verification / Validation – The right product doing the right thing (The article you’re reading).
Verificaiton and validation are both elements of the overall testing process. While the terms are sometimes used interchangeably, they really demonstrate very different aspects of the product testing process and should be used for the appropriate activity.