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.