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.
Product certification
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
Collaborative compliance
Compliance requirements are easier to meet when they’re part of the development process, not an afterthought. Nemko helps product teams identify potential issues earlier to reduce rework and simplify the path to approval.
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