Medical devices

MP diabetes 528678 1920  MP first aid 908591 1920  MP checklist 3222079 1920  MP hypertension 867855 1920   

SUPERA KVALITETA provides business consulting services in the field of medical devices

  • implementation of quality management system according to the requirements of ISO 13485:2016 in:
    • production
    • warehousing
    • servicing of medical devices
  • implementation, maintenance and improvment of
    • Good Manufacturing Practice - GMP
    • Good Distribution Practice - GDP
  • preparation of product technical documentation including Declaration of Conformity
  • clinical evaluation

We also perform internal audits and third-party audits in compliance with applicable regulatory requirements and standards. 

We organize and perform in-house trainings in English language for GxP, CE marking and other topics in the field of medical devices.