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Receiving CE Mark

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Guest user Created:   Sep 06, 2021 Last commented:   Sep 06, 2021

Receiving CE Mark

I consult a German company name ***. This company develop, manufacture dental implants and need the CE Mark soon in order to sell these items in Europe. We need to find a NB to perform an audit soon, and we can send the Technical File of the products to promote this process.
We can be audited to ISO 13485-16 or ISO 9001-15 what is the best to achieve the CE Mask soon.
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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 Sep 06, 2021

Since CE masks are medical devices, that it is recommended to implement and certified according to the ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.

Advisera has prepared the documentation toolkit that covers all requirements from ISO 13485:2016. Details about documentation toolkit you can find on the following link:

Also, we have prepared a lot of articles that cover necessary topics from the ISO 13485 which you can find on the ISO 13485 blog: https://advisera.com/13485academy/blog/

Furthermore, we have prepared several free webinars where you can hear and get basic information on the following topics: https://advisera.com/13485academy/webinars/

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Dr. Raanan Aloni Sep 06, 2021

please go on

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Sep 06, 2021

Sep 06, 2021

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