As previously mentioned by the fellow commentators, both the FDA and ISO requires a form of validation for medical devices. That being said, it all depends on the wording, this would make certain aspect of the validation process become more complicated which would require a verification process to go along with it. The validation procedure ensures that the process of the product is made to meet the specs and is optimized for the given application and its outputs can be replicated over and over again. Both FDA and ISO require full verification for a process that does not need validation. The FDA states that if the results are not fully verified after an inspection and test, then the process must be validated, approved and documented. Now with ISO, validation needs to occur when the output of the process cannot be verified after monitoring or measurement. It is up to the company to create the best method of validation that satisfies the requirements of the FDA and ISO. As mentioned prior which i agree, ISO provides an extra room for flexibility for companies to regulate the process output while the FDA it requires the monitoring of the entire lifecycle of the product to ensure it is consistent in terms of quality.