Staff

Gary Socola

Founder and President of HIGHPOWER Labs

Gary has been employed in the medical device industry since 1985 acting as a technical lead, quality, regulatory, or subject matter expert in the development of class II medical devices. Along with device development and validation, he has written patents, portions of American National Standards, and many successful 510k device submissions throughout his years of service.

He has extensive knowledge within the FDA QSR Part 820, GMP’s, ISO 13485 and ISO 17025 quality systems. He is a participant in the FDA’s Medical Device Advisory Committee for General Hospital and Personal Use Devices.

Gary is now involved in an advisory capacity at HIGHPOWER assisting when needed with medical device and sterilizer validation along with managing specialty projects.

In his spare time, Gary enjoys hunting and spending time with his five grandchildren.