Medical Certification
- Medical Devices 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 (MDD Annex VII).
- EC Type Examination Certificate (MDD Annex III).
- Full Quality Assurance with reference to EN ISO 13485 (MDD Annex II).
- Production Quality Assurance with reference to EN ISO 13485 (MDD Annex V).
- Product Quality Assurance with reference to MDD Annex VI.
- EC Verification MDD Annex IV.
The Nemko Direct Program for more challenging international approvals – they truly are a fast and competitive alternative