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ISO 14971:2019 - Risk Management Application on Medical Devices
Management
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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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.
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.
Course description
Course module
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5 Lessons
Fundamentals of Medical Devices' Risk Management Standard
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.
1.Learning Outcomes
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2.Fundamentals of ISO 14971
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3.Major Updates in ISO 14971:2019 & ISO TR 24971
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4.Important Terms for Medical Devices' Risk Management
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5.Lesson Summary
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5 Lessons
Essentials of ISO 14971 & ISO TR 24971
1 Lessons
Course assessment
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