You need this course if you work in the medical sector and are implementing a risk management system based on ISO 14971. Ideally you should have a sound knowledge of the medical devices manufactured by your organisation and it is advisable you understand the general knowledge of hazard analysis principles.
So with all that said, you will learn how to meet the Essential Requirements of the Annex I of the Directives and General Safety Performance Requirements of the Annex I of the Regulations.
As well executing on Annex 1 above,
- 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
Finally, you will gain knowledge surrounding risk management terminology and usability terminology and tools as defined in ISO 62366.
The course duration will be 2 days and encompasses a class room style, relevant and engaging exercises supported by comprehensive notes.