In my opinion, most of the challenge for project management of medical devices comes from the process (aka Design Controls). Developing medical devices requires a lot of detailed traceable documentation that must been done in a certain way. All of the hundreds / thousands of documents that are generated as a result of the development of medical device bust be maintained and managed in a DHF (Design History File). This file must be very well organized and include all of the proper documentation, since it can be audited (and mostly likely will be) be the FDA at any time. If the DHF is not maintained / created properly throughout the medical device project life cycle this could become a huge problem during or after the product has been released. If the FDA was to audit a DHF and the proper Design Control documentation does not exist, they can choose to take action based on the severity of the missing paperwork which could lead to pulling a product from the market if it has already been released. Being a project manager for medical device development means staying on top of all of the necessary Design Control documentation and DHF, on top of the regular project management that is needed for any other type of project in a different field.