We cover your compliance needs for product requirements (IEC 60601 series) as well as Quality Management System requirements (ISO 13485).
We are accredited according to ISO/IEC 17065 and ISO/IEC 17025.
Nemko provides international CB certificates for 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 Type Examination Certificate (Annex III)
- 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