Development of medical devices
Registration of medical devices
Organization of technical tests and toxicological studies
Introduction of amendments to the marketing authorization file and to the marketing authorization
Clinical trials of medical devices
Supervision of the medical devices circulation
Implementation of the Quality Management System
Fronika Group is a team of specialists who have been professionally engaged in work on medical equipment for more than 10 years, from its development, organization of tests, State Registration to mass production.
The company’s specialists are developers, registration managers, testers, and certified internal auditors of the Quality Management System. They improve their skills in these fields in the leading training centers in Moscow and St. Petersburg on a regular basis (All-Russian Scientific Research and Testing Institute of Medical Equipment, Center for Monitoring and Clinical and Economic Expertise, RSM Group, Russian Register, Resultat-Audit etc.). They took part in on-site inspections of Roszdravnadzor (on the part of the manufacturer), as well as review of the revealed violations at the commission meetings at Roszdravnadzor.
The company’s absolute priority is to honor the interests of the Customer!
Fronika Group Indicators
- more than 10 years of professional activity
- 98 marketing authorizations
- 90% with the first submission
- 12 cases at the stage of registration and introduction of amendments to the marketing authorization
Remote work with specialists and testing laboratories via personal account
Up-to-date documentation is available 24/7
Honoring the interests of the customer
Continuous monitoring of trends in industry-specific legislation
Availability of the design department