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ISO 13485 — Requirements for Regulatory Purposes Awareness

On-demand Training Course

ISO 13485 — Requirements for Regulatory Purposes Awareness

Level Understanding Duration 30 minutes
Available to book: On-demand elearning £85 + VAT Book now
Available to quote: In-house Buy multiple licences

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 and your teams 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. 

Having a consistent level of awareness across an organization can support employees to make informed decisions, enabling them to navigate complex situations with clarity and confidence. Ensuring everyone has a shared fundamental understanding of your management system can help embed continual improvement and maximize the benefits of having ISO 13485.

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 learners benefit?

This course will help you and your teams to:

  • 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
  • Upon completion of this course learners 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.


  • On completion, delegates will be awarded an internationally recognized BSI training course certificate.

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