VP, Quality & Regulatory Affairs
David Amor is an FDA/ EU Quality/ regulatory expert focused on combination products and digital health.
From NDAs and 505(b)(2)s to mobile app 510(k)s and Pre-INDs/ Q-subs, David has worked with over 45 medical device and pharmaceutical companies – large and small alike- supporting and/ or leading regulatory submissions and implementing quality management systems, including alignment of Agile-based SDLC programs to FDA and EU requirements.
He co-founded RemindTrac in 2014 (www.remindtrac.com), a digital health company for chronic patients, that continues to pioneer mobile care management systems today, and sold his consulting firm Medgineering in 2016.
David has recently led QA/RA strategy groups at Teva within the Digital Health Group, particularly in development of Agile-based Quality Management Systems, was a Principal Consultant in the CP/DH (Combination Products, Digital Health) group at Qara Partners, and served as the in-house risk management subject matter expert at Abbott (St. Jude Medical). He has served as the Director or VP of Quality at other medical device start-ups including AdrenaCard, Calcula, Enspero Medical and various others, and led multiple organizations through 483 and Warning Letter remediation projects, namely associated with risk management and design history file deficiencies, including Pfizer (Hospira), MID, Boston Scientific and St. Jude Medical.
Amor is a Top 40 Under 40 (MDDI 2015) and Top 35 Under 35 (MN Biz 2016) life science consultant and a Fellow Emeritus of the University of Minnesota Medical Device Center. As an adjunct professor at St. Cloud State University, David teaches graduate level quality, design controls and risk management courses for medical device students and participates in several AAMI Working Groups, including CP (Combination Products) Committee and ISO TC 210.
Lastly, David serves on the board of AdrenaCard, a combination drug-delivery auto-injector and is an active Angel investor for Gopher Angels in the Twin Cities.