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Clause 8.2.6 ISO 13485

ISO 13485 & EU MDR
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Chris P Created:   Jul 18, 2022 Last commented:   Jul 19, 2022

Clause 8.2.6 ISO 13485

ISO 13485 & EU MDR
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.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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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 18, 2022

Jul 19, 2022

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