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Appendix for Design and Development

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Guest user Created:   Feb 02, 2021 Last commented:   Feb 03, 2021

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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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:

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Feb 02, 2021

Feb 03, 2021

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Guest user Created:   Oct 12, 2020 ISO 13485 & EU MDR
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Design master file