Risk management is a process for identifying, evaluating and mitigating risk. For medical devices this means risks associated with harms to people and damage to property or the environment. Risk management has become an integral part of medical device design and development, production processes and evaluation of field experience. Risk management is applicable to all types of medical devices and evidence of its application is required by most regulatory bodies.
The management of risk for medical devices is described in ISO 14971:2007, Medical Devices–The application of risk management to medical devices. This course examines the standard using specific examples. Topics addressed include management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management.
Learning Objectives
Upon completion of this course, participants should be able to:
- Use risk management techniques to assess risk, including postmarket risk
- Define terms and understand concepts of risk management
- Identify guidance documents and standards for risk management
- Explain how risk management is integrated into design control, production and post-production
- Outline how risk management is practiced throughout the entire product lifecycle
Target Audience
This course is intended for experienced quality and regulatory professionals interested in the techniques of risk management as applied to medical devices.