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Design and Development Agreement

ISO 13485 & EU MDR
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Guest user Created:   May 16, 2022 Last commented:   May 17, 2022

Design and Development Agreement

ISO 13485 & EU MDR
Do you have a template for "Design and Development Agreement". I mean for outsourced process?
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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 May 17, 2022

No, we do not have a direct Design and development agreement, but we do have a document that is part of the folder 10_Purchasing and evaluation of supplier, 10.7_Appendix_7_Quality_Agreement_for_Subcontractor, that covers what is necessary for the provider of outsourced process. You can just tailormade it for the design process. 

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