Hello everyone, I hope everything is going well.

Dr. Simon mentioned in the lecture that you during the deign verification and validation phase, the engineer is supposed to kind of “make up a test.” I am completely sure that all these tests would vary depending on the biology, chemistry and physics of the medical device, but does the FDA suggest or demand specific tests? I am very curious to know how would you choose the correct tests for the Medical device. If anyone has Industry experience on this, I would appreciate the help and suggestions.

Thank you
-Roberto P.