Standard operating procedure (SOP) for risk management according to EN ISO 14971:2019 premium template download feature image

Standard Operating Procedure (SOP) for Risk Management according to EN ISO 14971:2019

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This is a downloadable word-file template for a standard operating procedure on risk management documenting a process as required by the ISO 14971:2019. It will help you achieve conformity with most requirements in ISO 14971:2019. The template includes example text and instructions on sections that are particularly important or may require explanations.


Why it is useful

The ISO 14971:2019 standard applies to all medical devices and in-vitro diagnostic devices put on the market in Europe regardless of classification. Having a streamlined and clear risk management procedure helps you implement the requirements from the standard and achieve compliance with the Medical Device Directive and In-Vitro Diagnostic Medical Device Directive. The procedure works well together with the other risk management templates made available on

How to use it

1. You may use this procedure template in your Quality Management System after adapting it to your needs and after removal of the informative text.
2. Use the template as an inspiration while authoring your own.
3. Use the template as a benchmark to check your own existing procedure.


If you have questions about the content of the template, you may ask questions in the support forum up to 10 days after your purchase. The support forum is accessible on this link when you are logged into your account. You can see other previously asked questions as well as ask any question you may have.

Need risk management training and a course certificate?

Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971:2019. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. Created by industry experts. Certification on successful completion of course.


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Would you like to learn more about risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course. These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.