The hidden stings of the Medical Device Regulation (MDR) – Annex VII

On-demand training course

The hidden stings of the Medical Device Regulation (MDR) – Annex VII On-demand training course

等級標準要求期間 1 hour

可報名: 線上隨選課程 NT$3500 Book your place

The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union. Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.

How will I benefit?

This course will help you:

Appreciate the requirements of Annex VII from the MDR
Gain a better understanding of some key Notified Body requirements within the MDR

Please Note

The course features interactive elements, knowledge checks, and comprehension tests. While we provide an estimated duration on the website, the actual completion time may vary based on your progress.
You'll have access to this course lasting 90 days from activation, allowing you to revisit and review materials whenever and wherever it suits your schedule.

By the end of the course you will be able to:
- Establish the requirements detailed in Annex VII of the MDR
- Appreciate the Notified Body prospective and approach when assessing against the MDR
- Gain an overview of the clinical evaluation requirements
- Understand audit duration and approach of Notified bodies as per the MDR
Quality, Regulatory, Technical professionals working in the Medical Device industry
1. Once you've completed your registration and payment, you'll receive a system-generated activation email with password set up instructions.
2. The course content can be accessed and reviewed multiple times within 90 days of receiving the activation email.
3. For course-related questions or technical issues, please contact:
- Ms. Maggie Chiang: 02-26560333 ext. 139
- Ms. Winnie Tsai: 02-26560333 ext. 145
, or email us at Maggie.chiang@bsigroup.com / Winnie.tsai@bsigroup.com
1. BSI reserves the right to make final interpretations of course-related policies.
2. To learn more about our On-Demand Courses, please visit our website.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
This is an online, interactive on-demand course.

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.

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.

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

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.

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

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