Engineering medical devices from concept to commercialization.
Engineering support aligned with applicable CDSCO requirements and international standards where relevant — delivered as an integrated mechanical, electronics, and firmware team.
Complete medical device engineering under one roof.
Regulated-grade PCB design, analog front-ends, sensor interfaces, and safety-critical power.
ARM/RTOS firmware architected with traceability, coding standards, and unit test coverage.
Enclosures, ergonomics, thermal, and materials selection for clinical environments.
ISO 14971-aligned hazard analysis, risk controls, and residual risk evaluation.
Test protocols, benches, and reports demonstrating design output meets input.
Usability, clinical, and environmental validation planning and execution support.
Design history file, technical files, and traceability matrices maintained end-to-end.
Documented handoff to manufacturing with pilot builds and process qualification support.
BOMs, work instructions, inspection plans, and DMR aligned to your QMS.
Design controls, from day one.
Intended use, user needs, and clinical context definition.
Formalized product requirements traceable to needs.
System partition across mechanical, electronics, and firmware.
PCB, mechanical CAD, firmware modules with reviews.
Bench and functional prototypes for engineering evaluation.
Design output verified against input with objective evidence.
Design validated in intended use environment where applicable.
Manufacturing readiness, pilot builds, DMR release.
Sustaining engineering and change control support.
Patient monitoring, therapeutic devices, diagnostic instruments, laboratory equipment.
STM32, NXP, ESP32, Linux SBCs, high-precision analog, isolated power, BLE/Wi-Fi.
IEC 60601-1 family, IEC 62304, ISO 14971, ISO 13485-aligned practices, CDSCO documentation.
Have a medical device concept?
Bring us a use case. We’ll design, prototype, verify, document, and support manufacturing.
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