Medical device software to IEC 62304
We build firmware and applications for medical devices in full norm compliance — and hand the legal manufacturer the complete technical file for certification. MDR-ready, GTelG-compliant, GDPR by default.
Norm-compliant by construction, not documented after the fact
Lead responsibility for regulated medical device software per IEC 62304 sits inside emergo's core team. We align the entire software lifecycle — architecture, risk management, verification and validation — to the standard from day one, rather than bolting compliance on at the end. As a data processor for the Medical University of Innsbruck, we already meet matching standards day to day.
What's included
Software lifecycle (IEC 62304)
Planning, architecture, implementation, verification and maintenance across software safety classes A–C.
Technical file & certification
Complete, auditable documentation for the legal manufacturer — MDR-ready, aligned with notified bodies.
Embedded & firmware
C, C++ and Zephyr RTOS down to custom PCB design — tightly coupled with cloud and mobile.
Risk management & V&V
Risk analysis, requirements-to-test traceability and automated verification.
Proven in practice
Examples: firmware for point-of-care electrolyte analysis (sodium/potassium), control and analysis software for oxygraphs in mitochondrial research, clinical platforms with ID Austria integration.
Frequently asked questions
Do you handle the IEC 62304 documentation for certification?
Yes. We hand the legal manufacturer the complete, auditable technical file — architecture, risk management, verification and validation evidence — aligned with the notified body.
Do you also build the embedded firmware and hardware?
Yes — from firmware in C/C++/Zephyr to custom PCB design, tightly integrated with cloud and mobile components.
Which IEC 62304 safety classes do you cover?
Classes A through C, including the associated risk management and requirements-to-test traceability.
Where is data hosted?
GDPR-compliant in Europe, or fully on-premise at the customer site — matching the needs of regulated industries.
Planning medical device software?
A 30-minute discovery call — an honest first take on feasibility, regulatory effort and timeline.