MDPharmaCourses | Regulatory, Quality and Compliance Training

Regulation 745/2017 on Medical Devices: technical file structure Duration: 1 hours Prerequisite: basic knowledge of medical devices and regulatory requirements in Europe Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers Contents: Annex I and Annex II of MDR; main contents expected in the technical file.

MDPharmaCourses | Regulatory, Quality and Compliance Training

The course is aimed at staff of Quality Assurance, Regulatory, and research and development of biomedical companies legalii manufacturers of medical devices of any class, who are in contact with the human body. The course describes the ‘risk-based approach in the planning of biocompatibility tests in vitro and in vivo. Level: Intermediate, it requires basic knowledge of Directive DM.

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