NEOEMKI Kft. is a Hungarian notified and accredited body specializing in conformity assessment of medical devices and certification of quality management systems according to EN ISO 9001 and EN ISO 13485 standards.

NEOEMKI Kft. (National Medical Device Conformity Assessment and Certification LLC.) was established in 2020 as a state-owned company in Hungary. Its primary aim is to perform conformity assessments of medical and in-vitro diagnostic devices as a Notified Body and to certify quality management systems as an accredited certification body. NEOEMKI Kft. operates in accordance with the highest ethical standards, ensuring independence, impartiality, and objectivity in its activities. It is a member of the Hungarian Standards Institution (MSZT) and actively participates in standardization activities. The company is accredited by the Hungarian Accreditation Authority (NAH) for the certification of quality management systems according to the EN ISO 13485 standard. The current accreditation status can be verified on the NAH website.

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