Design Review Record Template

49  (ex. GST/VAT)

This is a template for creating a design review record. You may have had your first design reviews already after establishing design inputs, but more commonly, design reviews are held during the execution phase of your project after a preliminary specification has been written, and sufficient detailed design work and/or simulation have occurred.
SKU PT-DRR Category Tags , ,

Description

Why it is useful

A design review record is required to record the results of design reviews. The purpose of the design review is to evaluate the adequacy of the product requirements and the design’s ability to meet the requirements.

How to use it

1. Design reviews must be planned. This may be done in the design and development planning or in the records from previous design review meetings.
2. Design review can be held by the developers of each subsystem of a medical. Often there will be multiple design reviews per subsystem. It may be appropriate to have multiple reviews as the design progresses. Remember, the goal is to detect issues as early as possible!
3. The project-level design reviews should be organized and led by the project manager.
4. Design users, resident experts, peer designers, and cross-functional team members should participate in these design review reports. For design reviews for products that are to be sold to US, one or several persons that are not directly responsible for the design stage being reviewed, shall be present on the meeting. This person(s) are often referred to as independent person. Ideally, this person shall be as competent in the field as the people doing the design work.
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.

Support

If you need help with this template, please go to our help page, and reach out to us if you have further questions.

Learn More

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.