Case Study 2: Clinical Trial QMS : Frestedt Incorporated

Situation	Start up active implantable medical device (AIMD) manufacturer needed development of a QMS to control conduct of an international clinical trial, managed through a CRO.
Frestedt Approach	Created quality documents for CRO/vender management Created a quality system to support clinical manager role and responsibilities Trained clinical manager and senior management on QMS
Results	Client successfully launched clinical trial and re-hired Frestedt Inc. to modify QMS as they brought CRO functions in house.

Case Study 2: Clinical Trial QMS