Introduction to this course: 

This course introduces ISO 14971:2019, the standard for medical device risk management. Explore key regulations, legal requirements, and essential risk management concepts to ensure compliance and safety.

Who should attend: 

This course is ideal for medical device professionals in quality assurance, regulatory, engineering, or manufacturing roles, with a basic knowledge of device development and ISO 13485:2016. It’s also perfect for those needing compliance with MDR 2017/745 and IVDR 2017/746.

Learning outcomes: 

By the end of this lesson, you will be able to:

• List key regulatory and legal requirements for medical device risk management.

• Explain the terminology and key concepts used in medical device risk management.

• Compare and contrast the risk management requirements of different regulations, such as US 21 CFR Part 820 and ISO 13485:2016. 

• Recall potential hazards, hazardous situations, and risks associated with medical devices. 

What will I gain: 

Participants will gain comprehensive insights into risk management for medical devices, its regulations, and its role in cost efficiency, recall avoidance, and building trust by ensuring safer devices.

Prerequisites: 

Participants should have a background in quality assurance, engineering, manufacturing, or regulatory affairs, with basic knowledge of quality management systems, regulatory requirements, and standards like ISO 13485:2016 and US 21 CFR Part 820.

Additional information: 

Course duration: 00:40:37

Course code/version (effective date): L-141/v1.0 (03/08/2023)