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Risk Management Report Template (ISO 14971, Medical Device)

Risk Management Report Template (ISO 14971, Medical Device)

49 € (excl. GST/VAT)

This template will provide you with a framework to complete your risk management report. It may also be used as a benchmark on your existing report. The template includes topics as required by clause 9 of ISO 14971:2019.

SKU PT-RMRT Category Tags , ,

Description

Why it is useful

A risk management report is required to conclude the risk management work that is carried out as part of a new product development project.

How to use it

1. Fill out the results of your risk management review in the corresponding section.

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before use of the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text customized to work with your current project.

 

Support

If you have questions about the content of the template, you may ask questions in the support forum. The support forum is accessible on this link when you are logged into your Medical Device HQ account.

Need risk management training and a course certificate?

If you should want to learn more about using the template or risk management in general, it is covered in our online Introduction to Risk Management for Medical Devices and ISO 14971 course and our public Risk Management for Medical Devices and ISO 14971 blended course. Our blended courses combine a self-paced online course followed by a live virtual classroom session. You can also save money by purchasing our Advanced Risk Management course bundle which includes 3 online courses at a reduced price.

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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.

SCHEDULED MAINTENANCE

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