CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

George Zack, Co-founder and Principal

Two Harbors

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George 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, 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 Medical Device Discovery Appraisal Program. 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.


MDDAP: Overview, Progress, and Next Steps

Conference Track: Improving Capability in the Medical Device Industry

The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has partnered with the Medical Device Innovation Consortium (MDIC), industry stakeholders, and CMMI Institute to build a pilot program aimed at shifting the industry from a mindset of compliance to one of continuous improvement. Learn how the pilot program works, key accomplishments and lessons learned, and next steps.

Panel: Building Capability in the Medical Device Industry

Conference Track: Improving Capability in the Medical Device Industry

Hear first-hand accounts of adopting CMMI V2.0 from participants of the collaborative FDA pilot program that endeavors to build a culture of quality across the medical device ecosystem. Enrolled device-makers receive a tailored evaluation appraisal to understand their capabilities against industry best practices and identify improvement opportunities. Panelists will speak to individual stories, broader themes, and answer questions.