Activity

  • Everyone raised some good points regarding verification and its importance. Verification is indeed an essential process in design control, and it can also aid in risk analysis. By verifying every aspect of a medical device (dimension, function, biocompatibility, life expectancy), you are able to learn more about the device, and what can be done to minimize any risks. Every medical device has its risks, which must be known and presented to the FDA. As stated already, in order to have a successful verification process, it must be able to test all aspects of the device. Even if its something minor, all factors matter and tests should be thorough. I think that time is also very important in verification, which means that a lot of time should be spent. Time should be managed accordingly to allow for failed tests to be fixed.