ISO 14971:2019 / EN ISO 14971:2019 - Risk Management for Medical Devices Training Course

Description

An effective risk management strategy is always evolving to meet global standards and requirements. for medical device manufacturers, this has meant developing a strategy that complies with both ISO 13485:2003 and the European Medical Device Directives.

Risk Management includes all phases of risk: Risk Analysis, Risk Evaluation, Risk Control and Post Production Information. Proper risk management requires an organized approach to provide a road map for assessing, assigning and reducing risk through the life of the device. The first step is the development of a risk plan that identifies the intended medical use of the device and addresses the risks at each phase of the life cycle of the product. Management needs to assign responsibilites to develop and carry out the risk to qualified personnel.

A Risk Management File documents the risk management process through records and other documents. You may include records as part of the file or reference records by the file. You will need to update the Risk Management File as you receive new information through the life of the product or the product family.

Audience

• Managers / executives / personnel who are involved in risk management processes for medical devices

• Personnel who are involved in the implementation and maintenance of quality management system according to ISO 13485:2003 Standard or those who wish to know more about risk management processes.