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.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
- How to manage design and development of medical devices according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/08/24/how-to-manage-design-and-development-of-medical-devices-according-to-iso-134852016/
- Design and development validation and verification according to ISO 13485 https://advisera.com/13485academy/blog/2019/02/14/design-and-development-validation-and-verification-according-to-iso-13485/
On the following link you can see the preview of documents regarding the design and development from our ISO 13485:2016 Documentation toolkit:
- Procedure for design and development https://advisera.com/13485academy/documentation/procedure-for-design-and-development-iso-13485-2016/
- Design and development file https://advisera.com/13485academy/documentation/design-and-development-file-iso-13485-2016/
- Design and development transfer record https://advisera.com/13485academy/documentation/design-and-development-transfer-record-iso-13485-2016/
- Change review record https://advisera.com/13485academy/documentation/change-review-record-iso-13485-2016/
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Mar 19, 2021