EN ISO 13485
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Certification body of quality management systems performs in accordance with requirements of ISO/IEC 17021-1:2015 certification of quality management systems for medical devices according to EN ISO 13485 within the following scope:
Non-active Medical Devices:
- General non-active, non-implantable medical devices
- Non-active implants
- Devices for wound care
- Non-active dental devices and accessories
- Non-active medical devices other than specified above
Active Medical Devices (Non-Implantable):
- General active medical devices
- Devices for imaging
- Monitoring devices
- Devices for radiation therapy and thermotherapy
- Active (non-implantable) medical devices other than specified above
In Vitro Diagnostic Medical Devices (IVD):
- Reagents and reagent products, calibrators and control materials for:
- Clinical Chemistry
- Immunochemistry (Immunology)
- Haematology / Haemostasis / Immunohematology
- Microbiology
- Infectious Immunology
- Histology/Cytology
- Genetic Testing
- In Vitro Diagnostic Instruments and software
- IVD medical devices other than specified above