EMKI-cert Kft. was established in 2019 with the aim of providing certification opportunities for Hungarian and foreign medical device manufacturers. Our employees have extensive experience in the regulation and certification of medical devices. We are constantly expanding the number of experts. Our ambition is to obtain accreditation for certification according to EN ISO 13485 in 2020 and submit our application for designation under the new EU medical device regulations, MDR and IVDR. Our employees are committed to helping medical device manufacturers to remain on the market and to place new production on the market by trainings and sharing professional documents.

Contact us:

EMKI-cert Ltd.
Headoffice: 1116 Budapest, Barázda u. 42. 4th floor
Phone number: +36 30 143 4642
E-mail address: info@emki-cert.hu
Managing director: Balázs György Ferenc

General Policy 

The EMKI-cert Medical Device Certification Kft. supports with its conformity assessment activities all those persons and organisations who use medical devices as patients or who sell, manufacture or develop medical devices as economic operators.
EMKI-cert Kft. carries out its activities in the field of quality management system certification and conformity assessment, but does not participate in the establishment, implementation or maintenance of a quality management system or in the draw up of technical documentation for medical devices, nor does it provide consultancy services.

EMKI-cert Kft. is a Hungarian company and therefore carries out its activities in accordance with domestic and European Union legislation, standards, and additional regulations, recommendations and national regulatory requirements. It is open to support clients from any country in the world who intend to produce, sell or use medical devices that meets domestic or European Union requirements. EMKI-cert Kft. nurtures, preserves and developes the proffessional culture that was founded by the 100-year-old Hungarian medical technology industry. To this end it pays special attention to the training and cooperation of professionally prepared, objective opinion-making, noncompliant and impartial employees in conformity assessment, independent and impartial from manufacturers and users, as well as professionals engaged in medical technology. The management and employees of EMKI-cert Kft. strive for a work that is a professionally demanding internationally recognized, transparent and valuable to its client. To this end, the management of EMKI-cert Kft. has put in place a documented management system and provides the necessary planning, regulatory, control, correction and infrastructural background. The management of EMKI-cert Kft. takes responsibility for the impartility and freedom of influence of the certification activity shall not be threatened by any commercial or financial pressure. The proccesses of the management system ensure the objectivity of the certification activity and the management of conflicts of interest.

EMKI-cert Kft. is committed to providing its quality service to the fullest possible service of its customers' needs, with a long-term relationship in mind and in a stable economic framework. It provides principals with clear information on terms and conditions of the undertaking as an independent enterprise. The name of EMKI-cert Kft. is linked by its certificate to the name of the certified medical device company. Hence, we are paying special attention to the fate of issued certificates.

Budapest, 30 July 2022

György Ferenc Balázs
Managing Director

The general policy of EMKI-cert Kft. is valid without a signature, the signed document is available at the office of EMKI-cert Kft.