Design and Development plan (Medical Device per ISO 13485 and 21 CFR 820) - Free Template

Design and Development Plan Template (Medical Device per ISO 13485 and 21 CFR 820) Free

This template will provide you with a framework to complete your design and development plan. It may also be used as a benchmark for your existing plan. The template includes topics as required by clause 7.3.2 of ISO 13485:2016 and §820.30(b) as required by 21 CFR 820.

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Description

Why it is useful

A design and development plan is required to ensure that the design process is appropriately controlled and that device quality objectives are met.

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 the other way around.

Interested in learning more about design control?

Take a look at our online course: Introduction to Design Control for Medical Devices. Learn about the overall design and development process and how design control requirements should be implemented. Created by industry experts. Certification on successful completion of course.

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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.