ISO 13485:2016 Medical Device Quality Management
A quality system for medical device manufacturers.
- Standard code
- ISO 13485:2016
- Certification type
- Management system (ISO/IEC 17021-1)
- Initial audit duration (45 employees)
- 6 man-days
CE support for machinery, electrical and construction products.
The CE mark shows, through the manufacturer's declaration, that a product meets the essential requirements of EU legislation. Which conformity assessment module (A, B+C, D, H and so on) applies depends on the product group and its risk.
At application we determine which directives your product falls under, review the technical file, risk analysis and test reports, and guide you on the declaration of conformity and marking rules.
If product photographs, the user manual and any test reports are sent before application, the applicable directive and module are clarified in the preliminary assessment.
| Output | Conformity report |
|---|---|
| Duration | 3–6 weeks |
| Scope | By product group |
A quality system for medical device manufacturers.
Customer satisfaction and the process approach.
Manage environmental impact and legal compliance.