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ISO 14971:2019 - Risk Management Application on Medical Devices

ISO 14971:2019 - Risk Management Application on Medical Devices

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ISO 14971:2019 - Risk Management Application on Medical Devices

Learn the fundamentals of the ISO 14971:2019 standard and its impact on the medical field in this free online course.

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ISO 14971:2019 - Risk Management Application on Medical Devices
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Learning Outcomes

In this free course, you will learn how to:

  • Discuss the reasons to update the ISO 14971:2019 standard
  • Describe how the ISO 14971:2019 standard corresponds with other standards
  • Outline the changes made in ISO 14971:2019 and ISO TR 24971
  • List the new terms and definitions which ISO added in the ISO 14971:2019 standard
  • Explain the annexes added in the ISO 14971:2019 and ISO TR 24971 standard
  • Discuss the composition of the ISO 14971 standard
  • Outline the changes in the ISO 14971 standard
  • List the specific changes made in the revised version of the ISO 14971 standard
  • Summarize the annexes, modifications, and clauses in the technical report of the ISO 14971 standard
  • List the risk management process steps in the ISO 14971:2019 standard
  • Explain the impact of ISO 14971:2019 in Europe

Knowledge & skills you will learn

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