You need this course if...
You work in the medical sector and are implementing a risk management system based on ISO 14971.
You will learn...
- How to meet the essential requirements of the Directives
- Risk management terminology
- Usability terminology and tools as defined in ISO 62366
- How risk management relates to the product life cycle
- How to implement risk management arrangements as required in ISO 14971
- How to update risk management files to meet the content deviations identified in Annex Z.
You will need...
- A sound knowledge of the medical devices manufactured by your organisation
- To have general knowledge of hazard analysis principles is advisable.
Available delivery methods
Delivered by one of our expert trainers who facilitates participation and discussion.
Work with our training experts to develop a training course or programme specific to your exact requirements.