The requirements of ISO 14971 are applicable to all stages of the lifecycle of a medical device. This course helps medical device professionals understand how ISO14971 can improve their business and risk management efforts. The student will gain an understanding of the impact that ISO14971 has on the decision-making process when manufacturing medical devices. After finishing the course, the student will gain the ability to work with risk management for medical devices according to the ISO 14971 standard.
Course Objectives of ISO 14971: Risk Management of Medical Devices
Identifying the links between ISO 13485 (QMS) and ISO 14971 (RM)
Explaining how risk management relates to the product lifecycle
Defining risk management terminology
Outlining the stages of the risk management process
Defining the key deliverables of the risk management process
Day 1
Introduction to risk management in medical devices
Links of risk management to regulatory requirements
The relationship of ISO14971 to other standards
ISO13485 and Risk Management
Understanding ISO13485
Day 2
The development of ISO14971
Why do we risk manage medical devices using ISO14971?
The Lifecycle approach
ISO14971 – Overview of the standard
Terms and definitions
General requirements of the standard
Day 3
The risk management process
The risk management plan
Risk analysis
Risk evaluation
Risk control
Day 4
Residual risk acceptability
Report/documentation
The Risk Management File Postproduction
IEC 606011:2005: Medical Electrical Equipment, General requirements for basic safety and essential performance
Day 5
Tools for Risk management
Failure modes and effect analysis
Fault tree analysis
Hazard analysis and critical control point
Summary and conclusions
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