Improve your risk management procedures

ISO 14971:2019/A11:2021 is now harmonized with EU Medical Device Regulation (MDR) 2017/745 and EU In Vitro Medical Device Regulation (IVDR) 2017/746 IVDR. 

Understand its importance and how it affects your business.

Risk must always be handled in a proper manner when working with Medical Devices. ISO 14971:2019 is an internationally harmonized standard, stating how to reduce risks, increase patient safety and ensure that you as a manufacturer can bring your medical devices to the market in a safe and efficient way.

Whether you are a medical device professional, or a beginner, you are responsible for your device’s properties and performance in relation to patient safety. As a result, it is essential that you understand risk management and how to work with it. 

This understanding will help and improve your risk management procedures when developing your medical devices as well as throughout the full product life cycle.

This course will provide you with a thorough understanding of ISO 14971:2019 and how adopting the standard early in the process will prevent risks throughout the device’s entire lifetime. In addition, you will learn how to ensure your products are compliant with the EU regulations and get the expertise you need to improve your business from a safety perspective.

Package content


Risk management training, pre-recorded module (1 hour) with certificate. Available for four weeks.


Risk management SOP with templates.


3 Workshops, 2 hours each.


Price: 43 000 SEK

The course is implemented for two months. Maximum participants: 10 people.

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Get in touch with our specialists to see what your company can benefit from this course package.

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