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Leon Assink, bSC

Senior Consultant
Medical Device Project

Quality and regulatory consultant in the area of medical devices, supporting manufacturers in achieving or maintaining certification for their quality management system and achieving or maintaining market approval for their medical devices. Performing training on quality management systems for medical devices, risk management and usability to medical device companies and participating in ISO workgroup on post-market surveillance. Over 10 years of experience in the medical devices field, both under the MDD and IVDD. During these 10 year period risk management was applied from different functions like Design change controller, R&D Manager and Quality Assurance / Regulatory Affairs.

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Presentation(s):