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Verification protocol (Design control, Medical Device)

49,00 € (excl. GST/VAT)

You have downloaded our Verification protocol template. This template will provide you with a framework to create verification protocols. Verification protocols can also be referred to as verification specifications.

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Description

Why it is useful

Verification and testing shall be performed in accordance with planned and document arrangements. Verification planning shall include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.
This template will help you address several of these requirements. It is appropriate to complement this verification protocol with a verification and validation plan.

How to use it

1. Establish verification protocols for each test or a group of tests, for example for a use case.
2. If you work with a paper-based system, copy the approved protocol for instance of the test you perform, thus the copied version becomes a form that will be filled out by hand when performing the verification which will then be the record from verification.
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 design control training and a course certificate?

We do our best to include instructions and example text needed for our templates. Nevertheless, if you should want to learn more about using the template or design and development in general, it is covered in two of our public training courses: Design Control for Medical Devices blended course and Project Management for Product Development of Medical Devices blended course. Our blended courses combine a self-paced online course first followed by a live virtual classroom session.

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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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