About the Course
Introduction to this course:
This course explores the structure, key concepts, and requirements of medical device QMS as per ISO 13485:2016.
Who should attend:
This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of the quality management system for medical devices.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall the structure and key components of ISO 13485:2016.
What will I gain:
Participants will gain a thorough understanding of the structure and key concepts of ISO 13485:2016.
Prerequisites:
Participants should have a basic understanding of quality management of medical devices. Familiarity with ISO 9001 and other international standards is beneficial.
Additional information:
Course duration: 00:36:51
Course code/version (effective date): L-148/v1.0 (07/09/2023)
Course Categories
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The fundamentals of medical device QMS
- Lesson 1: Medical Device Quality Management System
- Lesson 2: ISO 13485:2016: Structure, Clauses, and Key Concepts (Part 1)
- Lesson 3: ISO 13485:2016: Key Concepts (Part 2)
- Lesson 4: ISO 13485:2016: Key Concepts (Part 3)
- Lesson 5: ISO 13485:2016: Key Concepts (Part 4)
- Lesson 6: ISO 13485:2016: Key Concepts (Part 5)
- Reading: Differences between ISO 13485 and ISO 9001: When do I need each?
-
Additional resources
- Mind map: Risk Management for Medical Devices
About the Course
Introduction to this course:
This course explores the structure, key concepts, and requirements of medical device QMS as per ISO 13485:2016.
Who should attend:
This course is designed for professionals involved in QA/QC, compliance officers, regulatory affairs, manufacturing, and anyone who wishes to gain an understanding of the quality management system for medical devices.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall the structure and key components of ISO 13485:2016.
What will I gain:
Participants will gain a thorough understanding of the structure and key concepts of ISO 13485:2016.
Prerequisites:
Participants should have a basic understanding of quality management of medical devices. Familiarity with ISO 9001 and other international standards is beneficial.
Additional information:
Course duration: 00:36:51
Course code/version (effective date): L-148/v1.0 (07/09/2023)
-
The fundamentals of medical device QMS
- Lesson 1: Medical Device Quality Management System
- Lesson 2: ISO 13485:2016: Structure, Clauses, and Key Concepts (Part 1)
- Lesson 3: ISO 13485:2016: Key Concepts (Part 2)
- Lesson 4: ISO 13485:2016: Key Concepts (Part 3)
- Lesson 5: ISO 13485:2016: Key Concepts (Part 4)
- Lesson 6: ISO 13485:2016: Key Concepts (Part 5)
- Reading: Differences between ISO 13485 and ISO 9001: When do I need each?
-
Additional resources
- Mind map: Risk Management for Medical Devices