George Zack has been in leadership and contributor roles in information technology, software development and delivery, and process improvement over the past 20 years. George is Co-founder and Principal at Two Harbors Consulting, a firm focused on helping organizations achieve greater business value and performance results above compliance and regulatory expectations.George’s recent efforts include helping medical device manufacturers connect with FDA CDRH in the Case for Quality’s “ Voluntary Medical Device Manufacturing and Product Quality Pilot.” Prior to forming Two Harbors, George led McKesson’s regulatory and quality compliance audit program which performed quality system audits for registered medical devices and pharmaceutical distribution centers in the US, Canada, and Europe. George’s experience in process and continuous improvement also includes CMMI appraisal activities, value stream mapping engagements, Agile and other SDLC transformations, Six Sigma and enterprise tool implementations. Outside of his efforts with Two Harbors, George is a volunteer assistant coach to the local high school cross country and distance running squad, and is active in various roles with his son's Boy Scout Troop.
CMMI in the Healthcare Industry
The Medical Device Discovery Appraisal Program
Leveraging the internationally recognized framework of the Capability Maturity Model, medical device organizations are periodically assessed to determine their process capabilities and how they are continually improving the quality of their processes, systems and products. As part of being involved in the maturity model program, enrolled organizations are eligible for a set of regulatory benefits from the FDA. The CDRH Voluntary Medical Device Manufacturing and Product Quality pilot was announced in the Federal Register on July 25, 2017, with execution starting for early adopters of the program in Q4 of 2017.