Services for medical devices:
- Production of complete technical file for medical devices,
- Review of the existing technical file for medical devices and evaluation of missing information and documents
- Preparation of individual reports: risk analysis, clinical evaluation,
- Conducting and preparing report for Usability Study,
- Conducting and preparing report for Stability Study,
- Conducting and preparing Post-Market Clinical Follow-up Study
Experience: plastic products with measuring function (spoons and syringes for giving antibiotics, cups and bags for urine), various creams and gels, different systems for wound care (vaccum assisted therapy, different types of gauze, viscose and celuloze products, sponges and foams), disinfectants, dental materials, dental accessories (aspirator tips), different catheters (infusion, transfusion and urine), panels for operating rooms and clean rooms, accessories and kits for performing surgical procedures of non-woven materials, medical gases, orthopedic aids, diapers, electrodes and stimulators for head-scan.