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Stephan Affolter

Director Regulatory + Quality Intelligence
Ypsomed AG

After studies as Chemical Engineer at the University of Applied Sciences in Burgdorf, Switzerland with a degree as dipl. Chemist FH, BSc 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 23 years engaged in Drug delivery Device / Diabetes care industry in Quality Management and Regulatory Affairs in several management functions, currently as Director Regulatory + Quality Intelligence. 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 (i.e. ISO TC210) 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.

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