ISO 14971:2019 Risk Management for Medical Devices: Requirements On-demand Training Course

Duration 4 hours

Available to book: On-demand elearning PHP4500 See all dates and book

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This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices. It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745. Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course.

On-demand - training that’s even more flexible

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

This course will help you to:

Identify the key requirements of ISO 14971:2019
Interpret and communicate the key requirements and expectations of ISO 14971:2019 to your organization
Gain knowledge of how ISO 14971:2019 links to ISO 13485 and the regulations; MDR 2017/745 and IVDR 2017/746
Apply the fundamental risk management activities for medical devices within your organization

Upon completion of this training, you will be able to:
- Define risk management terminology
- Explain how risk management relates to the product lifecycle
- Outline the stages of the risk management process
- Define the key deliverables of the risk management process
- Apply risk management principles within your organization
- Identify the links between ISO 14971:2019, ISO 13485:2016, MDR 2017/745 and the IVDR 2017/746
This course is ideal for you if you’re in a QA/Regulatory/Engineering/Manufacturing role involved in medical device design, development and manufacturing.
Benefits of On-Demand for the individual

Convenient - courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection

Learning pace - You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue

Information retention - During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned

High-quality materials - Developed by top subject matter experts, course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
You should have experience with, or basic knowledge of, quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development, quality assurance and ISO 13485:2016

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