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Adrian replied to the topic Making up tests for design verification and validation in the forum Introduction to Design Controls 8 years, 4 months ago
I agree with most of that the FDA doesn’t demand specific test and to me this would be too much of an overhead and additional unwanted burden for them. I have some experience outside of BME with verification and validation, however, there is not much difference here. For each input requirement a test has to be created, and how to create the test will come from different source. One way is from either previous experience, or full understanding of the product from reading design doc and how to test it, or talking to the folks who wrote the requirements or the team that implemented the requirements. There is also understanding the standards and using it as a guideline to help in creating the test, and there are several other ways to approach this. In some cases you may need more than one test to verify a requirement.
So to your question, the test will depend on many factors including some that you mentioned like, biology, chemistry and physics. There should be a requirement specified to verify all aspect of these areas. In terms of validation the tests are more high level and one test can cover multiple functionality.Adrian