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Management
ISO 14971:2019 - Risk Management Application on Medical Devices
time1.5-3hrs
timebeginner level
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.
checked1Course description
checked1Course module
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Module 1
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.
course
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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Module 2
5 Lessons
Essentials of ISO 14971 & ISO TR 24971
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Module 3
1 Lessons
Course assessment
Comments5 Comments
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VinayKumar B.Augugust 24, 2025
It’s very detail & systematic way of approach
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Sohan Kumar T.June 20, 2025
It was just an amazing course, learn in detail with clear explanation
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Dr. Uqbah I.June 09, 2025
Great course
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Juancho M.June 07, 2025
Excellent Topic!!!
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Akshay N.October 30, 2024
Very well-crafted course.
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