Swiss Institute for Translational and Entrepreneurial Medicine (sitem-insel)

Module 6 - Risk Management and Usability Engineering

Andrea Schütz Frikart

Medtech Senior Specialist

Modules

Medical Device Regulatory Affairs and Quality Assurance

Module 6 - Risk Management and Usability Engineering

Biography

Andrea Schütz Frikart is a senior expert with 20 years experience in medical device development as a former development project leader at Roche Diabetes Care, as an inspector at swissmedic, the national competent authority and as a Senior Consultant to support international clients in the field of medical device and combination products as well as a lecturer for various institutes in Switzerland. She specializes in regulatory affairs, usability engineering and design control. She currently works as the Head of Human Factors and Usability Engineering at PharmaSens AG in Biel.