About
Founder of GMIS
GMIS is a boutique Contract Research Organization in Munich, Germany that focuses on providing tailored solutions to medical device companies to help them gain U.S. market access and to remain in regulatory compliance thereafter.
Ash is a results-oriented former medical device regulator with ten years experience at FDA who has deep regulatory knowledge and an even deeper network of colleagues. At the Agency he was a Regulatory Advisor for Pre-market Notifications (510k) and Device Determinations (513g) where he developed and articulated Center policy positions and helped carry out strategic initiatives. His responsibilities also included being part of the Not Substantially Equivalent (NSE) and Appeal committees for 510k’s where he administered authoritative guidance and advice to review staff in order to facilitate evidence-based and policy-backed decisions.
Ash was also a project and team lead of one of the largest consent decree of permanent injunction orders against a multi-national cardiovascular-focused corporation where he worked to get them back into regulatory compliance. He also led FDA efforts to get another multi-national organization to conduct a recall of their cardiac device.
His experience at the FDA also involved time in the Office of International Programs where he was a member of the analytics team and worked to enhance the contributions of FDA’s foreign offices (Europe, China, India, and Latin America) and headquarter’s needs on global issues and inspections by managing and identifying public health metrics and organizational objectives on regulated products entering the U.S.
As a self-proclaimed “techie,” Ash also has experience across FDA working on “special projects.” These include designing a field exam for surgical & isolation gowns now being used by U.S Custom’s and Border Patrol at the 25 largest ports across the country, and creating a risk-based ranking algorithm for future field exam development. He also designed a machine learning script to detect errors within the FDA's internal databases and to help the Center’s strategic selection of foreign sites for upcoming inspections.
Ash was also a member of the joint Strategic Science and Compliance Committee: on medical device program strategies and priorities to enhance laboratory optimization and work planning; and a member of the Case for Quality working group: which collaborated with industry to identify best manufacturing practices and metrics to be at the core of future compliance efforts; and a member of the Medical Device Single Audit Program (MDSAP) where he became a MDSAP assessor and ISO 13485 certified.
