When your device has 300β¦ 3,000β¦ or 12,000 requirements β Verification & Validation has reached an entirely new scale.
In this clip, Aaron Joseph talks about one of the most critical (and often underestimated) elements of medical device development: traceability.
In highly complex systems like surgical robotics, without clear requirement-to-test traceability, even great engineering looks disorganized.
At its core, strong V&V should clearly answer three questions for every single requirement:
β’ Where was it tested?
β’ How was it tested?
β’ How many samples were used?
Aaron on the πΊππππ ππ π½&π½ πΉπππππππππππ
Full episode
For reference Easy Medical Devices’ linkedin postΒ
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