Hello
From ISO 13485 with MDR, in 11 Production and Service Provision, is there enough in this document to cover off 8.2.6.
Document 11 does not mention 8.2.6 as a reference document. But I do not see anywhere else that does either.
thanks
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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
Expert
Kristina Zvonar Brkić
Jul 19, 2022
Yes, you are right, we did not put it in the first version of the toolkit. We are aware of this omission and it will be in the second version of the toolkit that will be released in September.
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Jul 19, 2022
Jul 19, 2022