ISO 14971:2019 - Application of Risk Management to Medical Devices Overview

ISO 14971 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks of these hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s QMS.

This two-hour self-paced risk management eLearning presents the key foundations of the risk management process defined in ISO 14971 and provides expert tips on how to navigate the process.

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

• Recognize the fundamental requirements in medical device regulation relating to risk management
• Explore the ISO 14971 step-wise approach to risk identification, assessment, control and evaluation
• Recognize the importance of risk management planning and a well-maintained risk management file
• Identify risk acceptability criteria and apply solutions for your own organization
• Identify key risk control measures to analyze, implement and evaluate risks individually, collectively and residually to reduce risk as much as possible
• Recognize the importance of post-market risk management to the overall process

This course is vital for any medical device professional looking to expand their knowledge of comprehensive risk management processes and to understand their interactions with the design and development activities of an organization.

By completing/passing this course, you will attain the Medical Device Certificate.