Regulatory, quality and clinical affairs

• Announcements (Forum)
• MDR - Medical Device Regulation EU 2017/745 (URL)
• IVDR - In Vitro Diagnostic medical devices Regulation EU 2017/746 (URL)
• Useful links (Page)
• Common acronyms (Glossary)

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• Slides - Introduction to EU Medical Device Regulation (File)

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• Preparation work for 27.02.2025 (Page)
• Slides - MDR and Classification (File)
• Slides - Classification exercises (File)

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• Slides - GSPR, Technical documentation (File)

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• Slides - Design and development (File)
• Slides - Requirements exercise (File)
• Exercice - correction (File)

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• Slides - Risk management part 1 - Updated 2025-03.20 (File)

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• Slides - Risk management process part 2 (File)
• Slide - Risk analysis exercise (File)
• Template - Risk analysis exercise (File)

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• Slides - Quality management - part 1 (File)

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• Slide - SOP Exercise (File)
• Template (File)
• Slides - Quality Management Part 2 (File)
• Exercice correction (File)

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• Slides - Clinical evaluation (File)

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• Slides - Clinical investigation - part 1 (File)

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• Slides - Clinical investigation - part 2 (File)

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• Slides - Medical Device Software (File)

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• Slides - Post Market Surveillance (File)

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