It is true that the engineer is supposed to “make up a test”; however, the test needs to reflect the section of the design requirements that the test will be verifying. In the Capstone class in NJIT, when we were designing our test plan, we had to specify which requirements in our requirements document the test was aiming to satisfy. Numerous tests had to be performed in order to verify all of the requirements we put out based on the customer needs. With that being said, according to the others in this forum, the FDA does not have specific tests that have to be performed for medical devices; however, there are guidelines and standards set by the FDA and other organizations that must be satisfied in the tests crafted by the device designers.