Activity

  • I agree with comments above that verification is important to ensure that all specifications originally laid out in the inputs are implemented correctly and comply with previously determined regulations/standards. As Dr. Simon mentions verification checks that ” inputs= outputs”. I also agree with @srg56 that its important to have realistic inputs to start with and that having a successful verification doesn’t mean that the device is safe. As mentioned in the Bonezone article, “Design verification should be achieved with test equipment calibrated and controlled according to quality system requirements”. The article also mentions using the design matrix as an important tool to ensure design inputs= design outputs. Like many have said its important to do think about the Verification stage earlier on when designing the inputs and that not performing appropriate verifications can be costly to the company. As a fun exercise, you should google image “medical device verification matrix”, there are many interesting/informative matrices.