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.