Development · Russia
Medical Device Development: Electronics, Software, Housing
Architecture, schematics, PCB, firmware, housing — compliant with IEC 60601 and ISO 14971 from day one.
What We Develop
Six Engineering Directions
PCB
Schematics & PCB
Architecture, schematic design, PCB layout, component sourcing, assembly
SW
Embedded Software
Firmware, interfaces, signal processing algorithms, software as medical device
MEC
Housing & Mechanics
Industrial design, biocompatible materials, injection moulding, 3D printing
LAB
Laboratory & IVD
Analyzers, test systems, sensor modules, cartridges — chemistry-optics-electronics integration
EMC
Pre-certification Prep
IEC 60601 and EMC design upfront to avoid costly redesigns at testing
DOC
Documentation
Specifications, design files, risk management file — foundation for registration dossier
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