Founder and Principal Consultant
Matrix Medical Device founder and visionary, Stephanie Harrington has over 20 years of management experience in the medical device industry with expertise in regulatory affairs, quality systems, product development, manufacturing, and clinical efficacy and market adoption studies. With strong technical skills, Stephanie has helped Companies and Clients establish savvy regulatory strategies that align with both short-term and long-term corporate objectives and are optimized to achieve marketable claims with the lowest regulatory risk, supported by achievable and applicable performance requirements and tests.
Over her career, she has prepared or overseen more than 30 medical device regulatory pre-market submissions with successful market approvals – FDA, CE, Australian TGA, Canada Licenses – over a range of medical device indication, complexity and risk, both therapeutics and diagnostics, e.g. IV Administration Sets, Arthroscopic Cannulas, Infusion Pumps, Endoscopes and Accessories, Temperature and Wellness Wearables, Novel and Traditional Imaging Devices, Interventional Cardiology, Spinal Implants and Sterilants/Sterilizers.
Stephanie has also established from the “ground-up” more than 30 FDA 21 CFR 820 and ISO 13485 Quality Systems, with many more remediated and streamlined, across small, mid, and large Companies. These Quality Systems, with well-practiced “objective evidence”, result in successful audit results from FDA, Notified Bodies, and “Big Ten” Medical Device Companies, including, as example, Medtronic and Abbott.
Through these experiences, Stephanie has built mutually-respected, collegial relationships with FDA, other Regulatory Agencies, and leading EU Notified Bodies such as BSI. Her experience, competency, technical understanding, and Regulatory Body relationships result in more efficient and successful Client pre-market clearances and approvals as well as QS audits. While some Consulting groups attempt to insert themselves “indefinitely” with Clients, Stephanie strives to use these Milestone deliverables as opportunities to identify potential internal Client Regulatory and Quality champions, to train, mentor, and grow the Client’s Regulatory and Quality organization, with our ultimate Matrix goal of the Client “graduating”, with less or no Matrix support needed the next time.
Prior to forming Matrix Medical in 2013, Stephanie served as Chief Operating Officer of Frantz Medical Development Ltd., responsible for new product development, manufacturing and corporate regulatory and quality affairs. Prior to joining Frantz Medical, Stephanie served as Vice President and Chief Regulatory and Clinical Officer at Imalux Corporation, a start-up optical coherence tomography imaging company, establishing the company’s Quality System, preparing and achieving multiple 510(k) clearances, as well as the first “OCT” FDA Product Code for non-ophthalmic use. Prior to Imalux, she was Director in Research and Development at STERIS Corporation, responsible for product development of medical device reprocessing systems.
Stephanie earned a Masters of Science degree in Chemical Engineering from Stanford University and holds a Bachelors of Science in Chemical Engineering, Summa Cum Laude, Honors in Engineering, from the University of Maryland.