We are accredited according to ISO/IEC 17065 and ISO/IEC 17025.
Product certification
Nemko provides internationalCB certificatesfor medical devices.
Medical device certification for Europe
Medical Device Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (Annex VII)
EC类型考试证书(附件3)
Full Quality Assurance with reference to EN ISO 13485 (Annex II)
Production Quality Assurance with reference to EN/ISO 13485 (Annex V)
Product Quality Assurance with reference to Annex VI
EC Verification Annex IV
Dedicated globalpartner
No matter if you are located in Europe, Asia, North America, or anywhere else in the world, Nemko’s international testing and certification facilities are here to help.
