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Design and development process

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Guest user Created:   Mar 18, 2021 Last commented:   Mar 19, 2021

Design and development process

I want to ask about clause 7.3 of ISO 13485:2016. If we produce a medical device that is equivalent to another device in the market but make some changes to it, is clause 7.3 applicable for us?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 19, 2021

Yes, clause 7.3 is applicable for you. It means that you must have documented procedure for the Design and development, and a form where you will fulfill changes that you have made, how you validate those changes and you transfer it to the production.

For more information please see the following links:

On the following link you can see the preview of documents regarding the design and development from our ISO 13485:2016 Documentation toolkit:

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Mar 19, 2021