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Clinical Investigation Submission Letter Template (ISO 14155, Medical Device)

49,00 €

This is a downloadable clinical investigation submission letter template for ethics committee review.

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Description

Why it is useful

This template of a clinical investigation submission letter is helpful when contacting an ethics committee for a review of your study. It can be used as a first draft or to improve your existing letter template.
It also works well with other template procedures available from medicaldevicehq.com.

How to use it

1. If you are preparing a clinical investigation submission letter, use this template as a starting point.
2. Use the template as a benchmark to review and improve your own template.
In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before the review of the document.
All texts that are not blue are example texts that can and should be edited by you and tailored to your situation.
Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed and the example text updated to suit your situation.

 

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 clinical investigation training and a course certificate?

Should want to learn more about using the template or clinical investigations in general, it is covered in our online course: Introduction to Clinical Investigation for Medical Devices and ISO 14155.

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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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