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Yaman Tunaboylu
Post Market Surveillance Manager at BioTronik AG

Profile

Yaman holds a Master of Science degree of the ETH Zurich. He has almost 20 years of industrial experience as development and safety engineer, thereof more than 14 in the medical device industry. Focus is on the organization and planning of global Post-Market Surveillance of both established and innovative devices like class III drug-eluting stents and scaffolds. He developed and established the corresponding quality management processes like Post-Market Surveillance system, Health Hazard Evaluation and Regulatory Compliance by implementing international regulations and standards like the EU-MDR, US 21CFR, ISO 13485 and the new PMS ISO TR 20416.

As an official Swiss expert in the international ISO and CEN standards working groups for PMS, quality management and surgical implants, he works on the global harmonization of medical device safety requirements since 2008 (ISO TC 210/ CEN JTC3 and ISO TC150).

As board member of the Swiss material science and technology association SVMT, he organizes seminars and workshops for biomaterial education and innovation. Besides PMS, areas of expertise are lifetime and structural integrity assessments by means of computer FE calculations, physical and experimental models.

Agenda Sessions

  • MANUFACTURER'S PERSPECTIVE: Interpreting Requirements for PMS Under the EU MDR

    11:05