H-1051 Budapest, Zrínyi u. 3.
Tel.: (1) 8869-300, Fax: (1) 8869-460
Mail: 1372 P.O. Box: 450.
Information about change on legislative requirements in prospect
Information about change in standard requirements
Documents related to EMKI’s operation
Certificating quality systems according to ISO 9001 and 13485 standards under the professional control of NAH accreditation body
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
Laws and regulations