ISO 14971 Risk Implementation.

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 organisation
• To have general knowledge of hazard analysis principles is advisable.

With LR, you can access a wide range of courses to help you further your career and bring improvements to the management systems in your organisation. With many learning styles to choose from, our training courses can help you develop and reach your next level. Find more courses here.

Two days.