Stephanie Harrington

About Stephanie Harrington

Matrix Medical Device founder and visionary, Stephanie Harrington has over 25 years of…

Experience

1. Chief Executive Officer

   Matrix Medical Devices

   Jul 2013 — Present · Mayfield Heights, OH, US

   Matrix Medical Devices provides Medical Device Regulatory Affairs, Quality Systems, Clinical Studies, and Product Development Consulting Services for start-up, mid-sized, and large Companies. Services range from project-based to contracted organizational leads for Regulatory, Quality, and/or Product Development, including:Medical Device Regulatory Services • US FDA and OUS Medical Device Pre-Market Applications o Pre-Submission Packages and Meeting Coordination o Device Classification, Predicate Device Selection, Regulatory Strategies o EU MMD 93/42/EEC to MDR Transitions o Application Preparation and Submission Point-of Contact: 510(k), 510(k) de novo, PMA, HUD, HDE CE Technical File, Design Dossier o Design Change Regulatory Assessment, 510(k) modification analyses• Adverse Events and Field Actions o MDR and eMDR Reporting o Diligence Reporting o Heath Hazard Evaluations, Bracketing, Health Risk Assessments o Recalls, Corrections and Removals• Annual Registration and Listing o US FDA Agent o FDA Establishment Registration and Device Listing o OUS License Renewal and Notified Body ManagementIn addition, Matrix Medical assists Clients with identifying and training QA/RA/R&D Candidates to build Client internal expertise.Since 2014, Matrix / Harrington has served as [virtual] Regulatory and Quality Organizational Lead for Medical Device Start-Ups until the Client\'s day-to-day activities grow to full-time, in-house support, e.g, innovative stroke therapy device, OCT imaging device, electrical nerve stimulation device, enterprise imaging software, electrochemcial biomarkers, enabling C-level support for due diligence, investors and board management, and regulatory and notified body negotiation at cost-effective % of a Full-Time Equivalent (FTE).

Education

• Stanford University School of Engineering

  Master of Science (M.S.), Chemical Engineering

  1990 — 1994

• University of Maryland

  BS, Chemical Engineering

  1985 — 1990

Skills

• Iso 13485
• V&V
• Patents
• Commercialization
• R&D
• Lifesciences
• Biotechnology
• Design Control
• Cross-Functional Team Leadership
• Start-Ups
• Product Development
• Technology Transfer
• Medical Devices
• Capa
• Pharmaceutical Industry
• Fda
• Biomedical Engineering