Challenge: A small, innovative U.S. company requested regulatory support for submission of a 510(k) for a new medical device.

Beaufort Solution: The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve its business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized it needed assistance with clinical trial management as well.  Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.

Date posted: October 27, 2011

Categories: Case Studies Clinical Research Regulatory Affairs