Learning Outcomes

Fundamentals of ISO 14971

Major Updates in ISO 14971:2019 & ISO TR 24971

Important Terms for Medical Devices' Risk Management

Lesson Summary

Learn about the clauses and annexes that were changed in the ISO 14971:2019 standard.  Why the standard was revised and how it aligns with other standards. Also there is an overview of changes made in the standard and its technical report, ISO TR 24971, and a collective explanation of the main changes in the standard and its technical report.

The ISO 14971 Standard

The ISO TR 24971 Standard

Process Steps of Risk Management in ISO 14971 & its Impact in Europe

learn the composition of ISO 14971, its standard ISO 14971:2019 and its technical report.  You will also learn the six risk management process steps in ISO 14971:2019, which are of great importance in industrial manufacturing processes. Lastly, the module covers the impact of ISO 14971:2019 in Europe.

ISO 14971:2019 - Risk Management Application on Medical Devices - Course Assessment

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

ISO 14971:2019 - Risk Management Application on Medical Devices

In this free online ISO certification, you will learn the risk management process in the manufacturing environment of medical devices. You will understand how ISO 14971 can help your organization comply with regulations and learn the new annexes, terms, and clauses in the updated ISO 14971 standard. Learn about ISO TR 24971 and how it helps in implementing ISO 14971. Also, learn about risk management in the standard and its impact across Europe.

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