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.
How you can help us?
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: