Class II device packaging services, CE mark
I work for a contract packaging house that is ISO13485:2016. I have a customer that has a Class II device they would like to package with us. They will be getting the item certified to EU standards to get the CE mark for it. The question I have is, does our 13485 ISO cert cover us to support the customer on this? Since we do not hold the 510k, but would be a part of the supply chain, is any additional certification needed for us to primary and secondarily package this Class II item?
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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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Apr 27, 2020