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Good People Working on Good Projects with Good Process

Case Study 2: Clinical Trial QMS

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.

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