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.