I actually have experience working as a test method development engineer for a medical device company (Becton Dickinson), working as this role your main job objectives are to develop and validate test methods that are used for design verification testing. Another part of this job role also includes identification and validation of the equipment that is needed for the DV (Design Verification) test methods. From my knowledge the FDA does not require any specific type of testing or give guidelines to how to perform any testing. There are other regulating bodies such as ISO that do require conformance to specific product performances based on the type of product you are manufacturing. For example if you are creating a medical device with a luer lock connection, ISO requires that the luer design that you are developing must meet certain assembly and removal force requirements. The high level parameters of the test methods are usually outlined by ISO but there are certain parts that are open for interpretation. It is up to the medical device company to identify the test equipment, develop the test method, and show that the product they are making conforms to all of the relevant ISO standards that are required. Other non ISO related project requirements are generally derived from the DID / DSD (Design Input Document / Design Specification Document). All of the product requirements that are outlined in either the DID or DSD need to have some type of an evaluation method so that it is possible to prove that the product meets those requirements. Not all of the requirements listed on the DID / DSD will require test methods, some may be rationalized or verified in other ways.