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Implementare la gestione del rischio ISO 14971 per dispositivi medici

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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.

Course length...

Two days.

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