Quality management at NemoStudio by Nemotec
Our commitment to quality
NemoStudio has the CE approval certificate granted by the Notified Body, complying with the most demanding European legislation.
NemoStudio also has the European certification UNE EN ISO 13485 (Quality Management System referring to Medical Devices) and ISO/IEC 27001:2013 (Information Security).
In addition, NemoCast, NemoFAB and NemoScan medical devices are approved by the FDA through 510(k), so they meet all the demands of the market and the dental professional.
ISO/IEC 27001:2022 by Rina
Certificate_Certificado ISO_IEC 27001_2022 by RINA.pdf
492KB
EC Certificate/Certificado
Certificate_Certificado CE 681105 – Full Quality Assurance System.pdf
388KB
ISO 13485:2016
Certificate_Certificado ISO 13485_2016 – Quality Management System for Medical Devices.pdf
459KB
NemoCast FDA Approved
FDA Approved for NemoCast K232549.pdf
516KB
NemoScan FDA Approved
FDA Approved for NemoScan K232698.pdf
2580KB
NemoFAB FDA Approved
FDA Approved for NemoFAB K192475.pdf
401KB
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