Michael Maier joined the Medical Notified Body (CE0344) of DEKRA Certification B.V. (former KEMA Quality B.V.) in October 2008 as head of the Swiss Office of KEMA Medical.
His hands on experience with bringing medical devices to the market is based on the projects he worked on as a freelance consultant, mandated for managing R&D teams, quality system implementation and regulatory affairs with his own consulting company, medidée sarl. Michael has experience in international projects in the fields of anaesthesia, orthopaedic and spine surgery, interventional radiology, ICU and CSSD; involving equipment and products as ICU ventilators, anaesthesia workplaces, MIC equipment, implants for osteosynthesis, sterilizers, vascular implants, VR-simulators for laparoscopy and interventional radiology.
Michael is member of SGSV (Schweizer Gesellschaft für Sterilgutversorgung), RAPS (Regulatory Affairs Professionals Society) and the section MD of SAQ (Swiss Association for Quality).
He is regularly speaker and trainer for medical devices, quality management and regulatory affairs related topics.