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Appendix for Design and Development
why, for example, the appendix for Design and Development are not all in one?
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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
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Kristina Zvonar Brkić
Feb 03, 2021
It was our opinion that transparency is better this way. Appendix corresponds to the sequence required by requirement 7.3 Design and development. If you put all Appendix together, start from Appendix 1 to Appendix 8, then you will have documented the whole process for the Desing and development.
You can find more information about Desing and development on the following link:
- 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/
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