SME Profile

Markus Zobrist QUALITY ASSURANCE / REGULATORY AFFAIRS


With more than 18 years experience in medical devices regulations, Markus Zobrist is a well recognized regulatory expert in Switzerland.
He has been with the Swiss Competent Authority for Therapeutic Products for more than 16 years and was involved in setting up the medical devices legislation in Switzerland following the European Directives. His working with the European Medical Devices Expert Group, ISO TC 210 WG1 developing ISO 13485:2003 and the Global Harmonization Task Force has given him an excellent insight in standards and regulations.
From 2006 until his retirement from Swissmedic in May 2008, he chaired the Global Harmonization Task Force Study Group 4 which is developing the international guidelines for auditing medical devices manufacturers.
Serving the educational needs of the medical devices community has been his passion after retirement from office, and Markus Zobrist is continuing to lecture on medical devices regulations at Bern University of Applied Sciences: www.bfh.ch and at ARIAQ: www.ariaq.ch