Risk Management Plan Template (Medical Device and ISO 14971) Free

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This template will provide you with a framework to complete your risk management plan. It may also be used as a benchmark on your existing plan.

The template includes topics as required by clause 4.4 of ISO 14971:2019. It also includes topics that should be addressed for software risk management according to IEC 62304:2006 and Amd1:2015.

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Why it is useful

A risk management plan is required by ISO 14971:2019 and if enables the effective risk management. The plan provides the roadmap for risk management, encourages objectivity and helps prevent essential elements from being forgotten.

How to use it

1. If you are developing a brand-new product, establish as much as possible of this plan in the planning phase of your project.
2. If you are making a revision of an old product or adding a product to a range that this plan applies to, the plan might only have to be updated slightly.
3. Note that the plan shall be maintained; that is, it should reflect what you are doing and not the other way around.

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 customised to work with your current project.

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. 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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