About Us

NEOEMKI LLC. (National Medical Device Conformity Assessment and Certification LLC.) is a business organization owned by the Hungarian State.

NEOEMKI LLC. was established with the aim of carrying out conformity assessment of medical devices and in-vitro diagnostic devices as a Notified Body, and as an accredited certification body for the certification of quality management systems as per EN ISO 9001 and EN ISO13485 standards.

Code of Conduct

We conduct our activity in accordance with the highest ethical rules, in the spirit of independence, impartiality and objectivity.

Organizational and Operational rules

The base of our activity is the Organizational and Operational Rules approved by the Ministry of Human Resources.

Company registration data

Annual report

Reporting, Complaint and Appeal management

NEOEMKI LLC. operates a procedure for handling incoming reports – especially cases that violate organizational integrity -, complaints and appeals. The procedure is reviewed by the company’s management from time to time to ensure that it is consistently appropriate, adequate and effective.