Risk Implementation ISO 14971 2018.

You work in the medical sector and are implementing a risk management system based on ISO 14971.

• 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.

• A sound knowledge of the medical devices manufactured by your organization
• To have general knowledge of hazard analysis principles is advisable.

Two days.