Introduction to Risk Management for Medical Devices
This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations.
Who should attend?
“The delegates were given freedom to discuss their own experiences and the tutor related these experiences to the course.”
- Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
- Decision makers on management system strategy
- Internal auditors
What will I learn?
On completion of this training, participants will be able to:
- Identify the links between ISO 13485 (QMS) and ISO 14971 (RM)
- Explain how risk management relates to the product lifecycle
- Define risk management terminology
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
How will I benefit?
You will gain an understanding of the impact that ISO 14971:2009 has on the decision making process when manufacturing medical devices.
- Training course notes