Gary has decades of experience in executive management and as an owner of small and midsize companies in the medical device sector. Employed in the medical device industry since 1985, acting as technical lead, quality, regulatory, executive management, owner and subject matter expert (SME) in the development of class II medical devices, their use within the industry, their required validation and subsequent reprocessing instructions.A consultant to medical device manufacturers, with a specialty in validating packaging systems, chemical indicators (CI), biological indicators (BI), as well as traditional/nontraditional sterilizers and sterilization processes used in healthcare facilities. Projects have included the validations of multiple healthcare sterilizers, packaging systems, BI’s, CI’s and thousands of class II medical devices. Mr. Socola has designed and developed medical devices, led root cause investigations, written patents and device 510K submissions and to date has never received a Non Substantial Equivalency (NSE) letter from the US FDA. An expert in the FDA’s QSR, Part 820, GMP’s, ISO 13485 and the ISO 17025 quality systems and currently sits on fourteen (14) working groups for the Association for the Advancement of Medical Instrumentation (AAMI) and International Standards Organization (ISO). He has authored sections within validation standards such as ANSI/AAMI ST55, ANSI/AAMI ST-77 (several in conjunction with the FDA) and has been called as an expert “Sterility Assurance” witness in legal trials.Gary established a medical device validation laboratory (HIGHPOWER Validation Testing & Lab Services Inc.) in 1993. The laboratory validates healthcare sterilizers, washer disinfectors, packaging systems (pouches, wraps and rigid containers) and specializes in reusable device cleaning, packaging and sterilization efficacy studies. At HIGHPOWER Gary developed a “Whole Package Integrity Aerosol Challenge Chambers” for the testing of sterilization pouches, sterilization wraps and rigid container systems. He also took part in developing an “Aerosol Challenge Chamber” for the testing of torturous path closure systems found in single use devices.As President of HIGHPOWER, Gary runs the day to day operations of a world class medical device validation laboratory. His knowledge of both the American and International standards and his unique ability to understand and work with the FDA’s Office of Product Evaluation and Quality makes his services in high demand but this insight has served him and his clients well over the past 30 years.