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

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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. It will help you achieve conformity with most requirements in ISO 14971. The template includes example text and instructions on sections that are particularly important or may require explanations.

Description

Why it is useful

The ISO 14971 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 MedicalDeviceHQ.com.

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.

Support

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.

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