What We Do
Medical Device Localization
Full route: from analysis of the foreign device to Russian production with Gov. Decree 719 status and registration.
Learn more →Legal Reverse Engineering
FTO analysis, functional decomposition and development of an independent technical solution without patent infringement.
Learn more →Medical Device Development
Architecture, schematics, PCB, firmware, housing — compliant with IEC 60601, EMC and registration requirements.
Learn more →Production & Assembly Lines
Production route, contract assembly, line setup and launch, ISO 13485 QMS and quality control.
Learn more →Registration & Documentation
Registration strategy, technical & operational documentation, testing, dossier, Roszdravnadzor and EAEU support.
Learn more →Market Analytics
Product hypotheses, registration database, government procurement, margins, barriers. Niche decision before money is spent.
Learn more →Typical Scenarios
Needs entry to the Russian and EAEU market: registration, local partner, production without losing product control.
First step: registration & production routeSupplies are disrupted or becoming more expensive, the market requires Russian-made status. Needs to become a manufacturer.
First step: localization assessmentHas a product or contract, lacks engineering capacity: PCB, housing, firmware, documentation, testing.
First step: engineering diagnosticsHas capital or capacity, needs a niche with clear economics and a team to bring to production.
First step: market analytics & product hypothesesSend a Request
Describe your device and task — we will respond within one business day.
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