Dear Valued Customers!
Keeping the safety of our employees in mind and in accordance with the travel restrictions worldwide NEOEMKI enters emergency procedure into force from 8th of September 2020.
The emergency procedure applies to all certification activities abroad.
Accordingly, NEOEMKI does not undertake initial certification where on-site visit required abroad.
For our certified clients NEOEMKI offers remote audits in accordance with the international guidelines and our internal regulation.
NEOEMKI LLC.
IMPORTANT NOTICE for our CERTIFIED CLIENTS (MDR compliance)
About Us
neoEMKI LLC. is a registered business organization founded by the Hungarian State.
Since 1st of May 2020 neoEMKI LLC. became the legal successor of EMKI Directorate of Device Testing and Clinical Engineering in relation to medical device conformity assessment activities.
neoEMKI LLC. aims to continue the conformity assessment of medical devices as a Notified Body and the certification of quality management systems according to ISO 9001 and ISO 13485 as an accredited certification body.
As part of its duties neoEMKI issues certificates on technical and professional parameters of device and authorization documents for reinbursement process (domestic clients only).
neoEMKI LLC. keeps trainings about the requirements of putting on market a medical device and on professional events its experts regularly give information about general expectations.
Thanks to last years professional activities, consecutive reformation and development, neoEMKI LLC. has a remarkable clientele, and is a known certification organisation internationally, not only in Europe but also on the American, Asian and African continent.
neoEMKI LLC. performs its certification routine according to rules of Code of Conduct (document of leading medical device Notified Bodies in Europe) and corresponds to the highest requirements.
Overview
Professional activity under the name “EMKI” is based on a remarkable, almost a half-century tradition.
Our predecessor in title, known as ORKI, was founded in 1962 and operated till 2001 as national testing laboratory in field of medical devices. Since 2001 it has been functioning as Notified Body. After Hungary has joined the European Union, ORKI turned up on international certification market. The organisation has been renewed in year 2011 responding to the change in medical device certification within the EU and performs its task under the name of EMKI (Directorate of Device Testing and Clinical Engineering).
Contact
| Location: | Albert Flórián út 3/a.Budapest 1097HUNGARY |
| Postal address: | H-1463 Budapest, Pf. 853HUNGARY |
| Telephone: | +36-20/268-7595 |
| Email: | cert@emki.hu |
| titkarsag@emki.hu |
Information
Change in legislative requirements
General information about certification process
Documents related to neoEMKI Ltd.
Certification of quality management systems according to ISO 9001 and 13485 standards
Certification of medical devices and compliance audit according to 93/42/EEC directive
Certification of IVD devices and compliance audit according to 98/79/EC directive