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Information on Certificates such as CoC / CoA or 3.1 certifications

ISO 13485 & EU MDR
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Guest user Created:   Jan 21, 2022 Last commented:   Jan 22, 2022

Information on Certificates such as CoC / CoA or 3.1 certifications

ISO 13485 & EU MDR
I am looking for more information on supplier documentation, specifically Certificates such as CoC / CoA or 3.1 certifications I woud like to know if there is a link to the ISO 13485 requiring suppliers to send us these types of certificates.. basically following DIN EN 10204
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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 Jan 22, 2022

It is up to the manufacturer to define which data from the suppliers are necessary. In requirement ISO 13485:2016, 7.4.2 Purchasing information is stated that product specification is one of the elements of purchasing information. So, you as a manufacturer define do you need a Certificate of analysis, Certificate of material, or similar.   

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