Training New MDR Regulation 2017/745 on Medical Devices: technical file structure
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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.