ISO 13485:2016 Course for Medical Devices QMS (updated 2024)

ISO 13485:2016 Course (updated 2025)

Learn about the international standard ISO 13485:2016 for Medical Devices Quality Management Systems.

1. Downloadable Material: ISO 13485:2016 Course PowerPoint Slides
2. Downloadable Material: List of references for ISO 13485:2016 Course
1. Lesson 1: Why do we need a Quality Management System?
2. Lesson 2: Scope and Applicability of ISO 13485:2016
3. Assessment 1: Lessons 1 and 2
1. Lesson 3: General QMS Requirements
2. Lesson 4: Documentation Requirements
3. Assessment 2: Lessons 3 and 4
1. Lesson 5: Management responsibility
2. Lesson 6: Resource management
3. Assessment 3: Lessons 5 and 6
1. Lesson 7: Product realization (Section 1)
2. Assessment 4: Lesson 7 (Section 1)
1. Lesson 7: Product realization (Section 2)
2. Assessment 5: Lesson 7 (Section 2)
1. Lesson 8: Measurement, analysis and improvement
2. Assessment 6: Lesson 8
1. Final Assessment: Video
2. Final Assessment
3. End of Course and Certificate of Completion

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