EN ISO 13485

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

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