Hartmut Loch serves as IVD Vision’s regulatory and compliance expert. He is also the President and CEO of Articular Spine Fix, Inc. and based in the IVD Vision facilities. Prior to that he worked since 2004 at Phygen, LLC, the largest physician-owned spinal implant manufacturer in the U.S., where he served as Vice President of Regulatory Affairs & Quality Assurance and was the Management Representative and Chief Compliance Officer until the acquisition by Alphatec Spine in 2013.
Before joining Phygen, he served as President & CEO of CVAC Systems, Inc. since 2002. From 1996 until 2002 he served as CEO and Director of Regulatory & Clinical Affairs & Business Development at PLUS Orthopedics, Inc. (now Smith & Nephews). Other executive positions included President & CEO at J.B.S. USA, Inc. until the acquisition by Aesculap AG in 1996, Vice President of Sales & Marketing of Thoratec, Inc., President & CEO of Amtech Scientific, Inc., and President & CEO at Cardiff Orthopedics, Inc.
Mr. Loch started his career with Aesculap AG in Germany and was transferred to help establish the U.S. subsidiary, where he managed the Division for OEM / Government Business and the Regulatory Affairs & Quality Assurance Departments. He graduated from Business School in Tuttlingen, Germany and earned a Certificate in Industrial Commerce & Business Administration from the German Chamber of Industry & Commerce in Rottweil, Germany. He also holds a B.S. in Business Administration and completed the RAPS Executive Development Program at the Kellogg School of Management, Northwestern University, Evanston, IL.
Mr. Loch’s Regulatory, Quality & Compliance experience includes:
1) authoring 3 IDEs and subsequently monitoring the clinical trials with 1,650 subjects at 45 hospitals across the U.S.
2) writing and receiving approvals for over 60 FDA 510(k)s class II and class III
3) authoring and receiving FDA 510(k) approval for the Galileo CAS/NAV TKR System (surgical robot)
4) assisting in US FDA PMA for ventricular assist devices and International PMA for small diameter vascular grafts
5) establishing several quality systems according to GMP, FDA QSR Part 820, ISO 9001 and ISO 13485
6) designed, established and managed full-service quality laboratory meeting FDA, DOD & DPSC specifications
7) conducting over 20 supplier quality audits in the U.S. and overseas
8) establishing and directing corporate compliance programs
Mr. Loch was selected Industry Expert on Medical Devices by the US General Accounting Office (US GAO) in Washington, DC in 1983 and received Regulatory Affairs Certification (RAC) in 2000.
He served on the panel for surgical instruments for the Association for the Advancement of Medical Instrumentation (AAMI) and on the technical committee for alloy implant materials for the American Society for Testing and Materials (ASTM).