ISO 13485 — Requirements for Regulatory Purposes Awareness

On-demand Training Course

ISO 13485 — Requirements for Regulatory Purposes Awareness

等級標準要求期間 0.5 hour

可報名: 線上隨選課程 NT$2500 Book your place

Quality Management systems (QMS) in the medical device world is critically important to the safety of patients around the world. BSI has developed a short session that makes you aware of what ISO 13485 is, why it is important and how your organization can use it to help maintain patient safety. It also considers how you are a vital piece of the jigsaw and what you can do to help your organization.

How will I benefit?

This course will help you:

Understand what an ISO 13485 quality management system is
Appreciate why ISO 13485 is important to your organization
Recognize the importance of ISO 13485 and patient safety
Identify how your activities play a role in ensuring safe medical devices

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.

Upon completion of this course, you will be able to:
- Understand why ISO 13485 quality management systems are important
- Appreciate how your role is relevant to the ISO13485 QMS
- Recognize the benefits of an ISO13485 QMS for your organisation
- Describe why ISO 13485 is important in helping ensure patient safety
All staff especially those who are within scope of an ISO 13485 management system.
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 course 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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