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Design and development plan template (medical device per ISO 13485 and 21 CFR 820)


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This template will provide you with a framework to complete your design and development plan. It may also be used as a benchmark on 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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Product 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.

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