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Jeremy Tinkler
Chairman of ISO/TC 194 (biological and clinical evaluation of medical devices) Director of Regulatory Consultancy and Quality Assurance at MedPass Intl


Jeremy Tinkler worked for 10 years as a toxicologist in laboratories and the UK Health and Safety Executive before spending 20 years at MHRA where, as Principal Specialist in Biosciences and Implants, he combined responsibility for biological safety assessment with regulation of a wide range of cardiovascular, plastic surgery and other implants, human and animal tissues, adverse event management and quality assurance audit.  He joined MedPass in 2007 where he expanded strategic consulting activities in the area of clinical evaluation and market access. Since the 1980s he has participated in several European Commission Working Groups (e.g. developing MEDDEV 2.7/1 on clinical evaluation) and taken a leading role in standards development in biological safety, risk management, clinical investigation and implants.  He now focuses once again on biocompatibility and is Chairman of ISO/TC 194 (biological and clinical evaluation).

Agenda Sessions

  • Current and Upcoming Challenges in ISO 10993