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Is ISO 13485:2016 Quality Manual Template compliant with MDR?

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Michael Shaffer Created:   Jul 08, 2022 Last commented:   Jul 14, 2022

Is ISO 13485:2016 Quality Manual Template compliant with MDR?

We(a U.S company) implemented and certified ISO 13485:2016 using Advisera's template package last year. I could never understand the "_EN"  at the end of the Procedure titles. We are now working with an NB to certify a class IIa product for MDR and MDSAP to sell outside the U.S. I now think I understand the " _EN". Prior to the audit our NB wants me to verify / confirm whether our Quality Manual meets the requirements of EN ISO 13485:2016 as well as MDR. Can you confirm this? The only gap I see is that Post Market Surveillance is not mentioned in the Quality Manual but I'm not sure it is a requirement for the Quality Manual.
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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 14, 2022

EN means that the toolkit is in English. But, the toolkit is prepared so that it is in compliance with MDR. 
You are right that PMS is not directly mentioned but it is not the requirement to be in the Quality manual. You have the procedure for PMS and all other documents.  

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Jul 08, 2022

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