About the Course
Introduction to this course:
This course covers Clauses 7 and 8 of the ISO 13485:2016 medical device QMS. Clause 7 focuses on the requirements for planning product realization, while Clause 8 addresses the requirements for measuring, analyzing, and improving medical devices.
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 ISO 13485:2016.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall the fundamentals to develop a comprehensive product realization plan for a medical device ensuring compliance with ISO 13485 standards.
Recall the key elements to assess the effectiveness of the design and development processes.
Explain the importance of monitoring and measurement in ensuring the effectiveness of the Quality Management System (QMS) as per ISO 13485
What will I gain:
Participants will gain a solid understanding of the foundational clauses of ISO 13485:2016, enabling them to ensure compliance and improve their organization’s quality management system.
Prerequisites:
No prior knowledge of ISO 13485:2016 is required, but familiarity with general quality management principles is beneficial.
Additional information:
Course duration: 00:20:29
Course code/version (effective date): L-1411/v1.0 (29/09/2023)
Course Categories
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Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
- Lesson 1: Introduction and Clause 7: Product realization (Part 1)
- Lesson 2: Clause 7: Product realization (Part 2)
- Lesson 3: Clause 7: Product realization (Part 3)
- Lesson 4: Clause 8: Measurement, analysis, and improvement
-
Additional resources
- Mind map: ISO 13485:2016
About the Course
Introduction to this course:
This course covers Clauses 7 and 8 of the ISO 13485:2016 medical device QMS. Clause 7 focuses on the requirements for planning product realization, while Clause 8 addresses the requirements for measuring, analyzing, and improving medical devices.
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 ISO 13485:2016.
Learning Outcomes:
By the end of this lesson, you will be able to:
Recall the fundamentals to develop a comprehensive product realization plan for a medical device ensuring compliance with ISO 13485 standards.
Recall the key elements to assess the effectiveness of the design and development processes.
Explain the importance of monitoring and measurement in ensuring the effectiveness of the Quality Management System (QMS) as per ISO 13485
What will I gain:
Participants will gain a solid understanding of the foundational clauses of ISO 13485:2016, enabling them to ensure compliance and improve their organization’s quality management system.
Prerequisites:
No prior knowledge of ISO 13485:2016 is required, but familiarity with general quality management principles is beneficial.
Additional information:
Course duration: 00:20:29
Course code/version (effective date): L-1411/v1.0 (29/09/2023)
-
Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8
- Lesson 1: Introduction and Clause 7: Product realization (Part 1)
- Lesson 2: Clause 7: Product realization (Part 2)
- Lesson 3: Clause 7: Product realization (Part 3)
- Lesson 4: Clause 8: Measurement, analysis, and improvement
-
Additional resources
- Mind map: ISO 13485:2016
