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Stephan Affolter
Regulatory + Quality Intelligence Manager at Ypsomed, Switzerland


After studies as Chemical Engineer at the University of Applied Sciences in Burgdorf, Switzerland with a degree as dipl. Chemist FH, BS he was working about 10 years in Food, Drug and Biotech industries in different leading QC/QA/QM/RA and Production functions, incl. Qualified Person.

Since more than 19 years engaged in Drug delivery Device / Diabetes care industry in Quality Management and Regulatory Affairs in several management functions, currently as Regulatory + Quality Intelligence Manager. Further education as Quality- and Process manager SAQ, Quality Manager EOQ, Lead-auditor ISO 9001/13485/14001 and Regulatory Affairs.

He is contributing in development of current standards and guidance documents in national and international standards committees (ISO) and working groups (i.e. PDA, MPP, Swiss Medtech). He is board member of the industry association Medtech & Pharma Platform MPP, which supports the collaboration of the different industries with focus on combined products.

Agenda Sessions

  • Industry Perspective - Regulatory Focus on Device Components Within the New EU Framework


Speakers at this event