Introduction to this course: 

This course examines the risk management process for medical devices, including software as a medical device (SaMD) and in vitro diagnostic medical devices. It involves identifying the hazards associated with the medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring their effectiveness.

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:

• Describe the key components of the ISO 14971:2019 risk management process for medical devices, including risk assessment, risk control, risk management review, and production and post-production activities.

• Implement risk management principles by conducting a risk analysis that includes hazard identification, risk estimation, and risk evaluation for a given medical device.

• Examine case studies of medical devices to identify potential hazards and hazardous situations, and evaluate the effectiveness of risk control measures applied.

What will I gain: 

Participants will gain skills to assess and control risks throughout the medical device’s lifecycle, and a robust understanding of risk-benefit analysis.

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: 00:20:46

Course code/version (effective date): L-142/v1.0 (03/08/2023)