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)