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