Medical Device Engineering
Regulatory-Ready
Medical Devices.
From Day One.
IEC 60601-1, FDA 510(k), ISO 13485. Full-stack medical device engineering from a team that builds for compliance — not around it. Senior architects. No juniors.
Capabilities
End-to-End Medical Device Engineering
Regulatory-Ready Architecture
Design controls and risk management built in from day one — not bolted on at month 12.
Design Controls & Quality
Traceability, DHF documentation, and QMS alignment for audit-ready submissions.
Firmware for Medical
IEC 62304-aware software lifecycle for safety-critical embedded systems. Class B and C.
Full-Stack Hardware
Analog front-end, low-noise sensing, BLE/Wi-Fi, power management, PCB through rigid-flex.
Real Project
Nasal CO2 Measurement Device
Medical Device Startup — FDA-Pathway Medical Device
Reduce Your Regulatory Risk
Tell us about your medical device. We'll schedule a free consultation to discuss regulatory pathway, architecture, and how Kyros can compress your timeline to market.
Talk to Our FounderFrequently Asked Questions
- What medical device standards do you design to?
- IEC 60601-1 and 60601-1-2, FDA 510(k)/PMA/De Novo pathways, ISO 13485 quality systems, and ISO 14971 risk management — built into architecture decisions, not added at the end.
- Can you take a medical device from concept to submission-ready?
- Yes. We cover firmware, electronics, and systems from architecture through verification, producing the documentation and traceability a regulatory submission requires.
- Who owns the IP and deliverables?
- You own everything — source code, schematics, Gerbers, BOMs, and documentation. We do a full knowledge transfer and design for clean handoffs, not lock-in.