History of the Fronika Group LLC
- Starting works on the pre-inspection audit of manufacturers of medical devices within the context of registration according to the rules of the EAEU. Training our own production inspectors. Registration according to the rules of the EAEU.
- Joining resources under the common brand of FRONIKA GROUP. Trademark registration.
- Organization of business consulting services in the field of state supervision of the medical devices circulation. Conducting audits of production, updating technical, operational, and QMS documents. Organization of procedures on the introduction of amendments to the marketing authorization file.
- Starting works on the implementation of the quality management system based on GOST ISO 13485. Evaluation and development of documentation on the quality management system. Training of our own auditors.
- Starting procedures for state registration of medical devices within the framework of the Resolution of the Government of the Russian Federation of December 27, 2012 N 1416 “On approval of the Rules for state registration of medical devices”.
Launching the project support program (project managers) within the context of the execution of state contracts in the field of medical devices
- Expansion of the development team, consisting of mechanical and electronics designers, programmers, opticians, and researchers. Starting the development of medical devices (medical equipment)
- Starting work with production companies (development of quality management systems, commencement of production, author’s supervision)
- Organizing a professional development team in the field of research and development of optoelectronic devices (engineering calculations, design development, preparation of technical and operational documentation)
Some marketing authorizations from our portfolio