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Risk management file index template

Risk Management File Index Template (ISO 14971, Medical Device)

29,00 €

This downloadable Risk management file index template will provide you with a list of some typical documents and records that should be part of your risk management file and an index to reference them.

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Note: Risk management for medical devices templates are included in the blended course.

Description

Why it is useful

This index will facilitate the auditing of your risk management file.

How to use it

1. Fill out the relevant references to your documents and records that are related to risk management.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before review 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 customised to work with the 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 Risk Management for Medical Devices and ISO 14971 online course and our blended course Risk Management for Medical Devices and ISO 14971:2019 – Practitioner Training. 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.

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