Receiving CE Mark

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:

• ISO 13485 Documentation Toolkit https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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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