ISO 14971 Risk Implementation

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  ISO 14971 Risk Implementation

  2 Days

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
  • General knowledge of hazard analysis principles is advisable

Dates and Venues