Medical Devices Expert

Fronika Group. Every Day Matters©

About us

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

Our advantages

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

Continuous improvement

Availability of the design department

Our Partners

Testing laboratory of technical means according to safety requirements Electrontest LLC

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