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

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.

Support

If you have questions about the content of the template, you may ask questions in the support forum up to 10 days after your purchase. The support forum is accessible on this link when you are logged into your account. You can see other previously asked questions as well as ask any question you may have.

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.