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 ISO 13485:2016 standard.
NEOEMKI LLC. carries out the conformity assessment of medical devices as a Notified Body in accordance with the EU Regulation 2017/745 (MDR).
NEOEMKI LLC., as an accredited organization, carries out certification of quality management systems according to the ISO 13485:2016 (EN ISO 13485:2016) standard in accordance with the requirements of the MSZ EN ISO/IEC 17021-1:2016 standard.
NEOEMKI LLC. does not have any subsidiaries.
The certification procedures are carried out by our employees with several years of relevant professional experience. We continuously develop our internal resources, processes, management and controlling systems in order to ensure our professional and organizational development.
NEOEMKI LLC. is an impartial, professionally prepared organization, independent from medical device manufacturers, distributors and users. In our activities, it is ensured that external persons or organizations do not influence the objective results of the tests.
We pay special attention to impartiality and confidential handling of information.
Statement of confidentiality, independence and impartiality of the management of NEOEMKI LLC.
NEOEMKI LLC. has liability insurance for the performance of services under the certification contract.
The liability for damages of the NEOEMKI LLC. extends only to the extent of the liability insurance coverage. Since the geographical scope of the policy does not extend to the entire world, NEOEMKI Ltd. does not perform certification activities in the USA, Canada, Australia and New Zealand.
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.
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.