Engineering & Regulatory Center

From foreign analogue or idea — to a Russian medical device ready for production and registration

Localization, engineering, contract manufacturing and MD registration — as one integrated project.

GMT med-local.ru rzn.expert Ossoria

Group Structure

Four Directions — One Contour

Parent company. R&D and proprietary products as the result of localization.

Engineering core: reverse engineering, electronics, software, housing, localization route.

Registration of localized MD and IVD: dossier, testing, marketing authorization and EAEU.

Localization facility in Shatura: PCB assembly, housing, injection moulding, software.

Team

Russian Healthcare Week, expert session (Expocentre, Moscow)

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CEO and co-founder of GMT LLC (80% stake)

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PhD candidate, IBCP RAS: porphyrin-polymer nanoparticles (purpurin-18 in PLA/PEG matrix)

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ISO 13485 and ISO 14971 auditor, EAEU MD registration — VNIIIMT

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Co-founder of AUSOMI industry association · Speaker at Russian Healthcare Week

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Career: R-Pharm (Sputnik V QC) → Regfort → Delnous → GMT

References

Contact details provided upon request. Currently 30+ active projects.

LLC "Master"Support and receipt of 2 marketing authorizationsG004-00110-00/04506917

LLC "NPO DEOST"Support and receipt of 1 marketing authorizationRZN 2025/26379

Baihe Medical (China)UPP services, production inspection, reportNo. IP-24-554

Pirogov RNRMUDevelopment of multiplex ICA testMyocarditis diagnostics, TRL 3

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