Gunter Frey headshot

Gunter Frey

Executive Director, Quality Systems

Medical Devices

Gunter Frey has nearly 30 years of experience in developing and implementing quality systems in the medical device industry. Mr. Frey has extensive experience in the manufacture of diverse medical devices and combination products including verification and validation activities, practical application of international standards, regulatory affairs, complaint handling and reporting, and corrective and preventive actions. His experience also includes guiding and executing remediation efforts and resolving complex compliance gaps for large international companies. As a member of Study Group 3 of the Global Harmonization Task Force, and various technical committees, Mr. Frey significantly contributed to the writing of international standards, such as ISO 13485, as well as guidance documents.