One of the biggest challenges of doing project management for a medical device as opposed to building a building is having to assure that the device in question is meeting vigorous FDA regulations and that all other documents such as human testing applications and such are in order. The project manager is to assure that any documents such as technical requirements and test plans are in order in order to proceed in a project; however, the extra hurdle with medical devices are the regulations and those have a slew of documents on their own. This can also hinder scheduling for a project manager since getting these documents approved on time is not up to the project manager, but the third parties which can request even more documentation that may or may not exist. This is why drugs often go through years of pre-clinical and clinical trials before entering the market; these strict regulations on medical devices could affect the flow of the project depending on what level medical device is being developed.