Medical Device Firmware
Medical Device Firmware Consultant: What to Look For
A medical device firmware consultant should pair deep embedded expertise with regulatory rigor. Kyros Engineering develops medical device firmware senior-led — with IEC 60601-1, IEC 62304, FDA 510(k), ISO 13485, and ISO 14971 designed in from day one, and a principal engineer who owns the project from architecture through verification.
How to choose
What to look for
Regulatory fluency, not just code
The right consultant designs to IEC 62304, IEC 60601-1, and the FDA pathway from the first architecture decision — not as a documentation scramble before submission.
Safety-critical embedded depth
Class B/C software, RTOS, MCU bring-up, fault handling, and safe states — proven on real hardware, not slideware.
Submission-ready evidence
Design controls, DHF documentation, traceability, and V&V produced alongside the firmware, so the regulatory package is built in.
Senior accountability
A principal engineer who owns the outcome end to end — not a rotating cast of juniors you have to manage and re-explain context to.
How Kyros compares
| Criterion | Kyros Engineering | Typical contractor / staffing firm |
|---|---|---|
| Regulatory pathway | IEC 62304 / 60601-1 / 510(k) designed in from day one | Firmware first, compliance bolted on later |
| Who leads the work | Principal engineer owns architecture → verification | Individual contractor or junior-heavy team |
| Documentation | DHF, traceability, V&V produced with the firmware | Code only; docs are your problem |
| Accountability | Single senior point of accountability for the outcome | You direct and quality-check the work |
| IP & handoff | You own all source/docs; full knowledge transfer | Lock-in risk; thin handoff |
Frequently asked
What should I look for in a medical device firmware consultant?
Embedded depth (RTOS, MCU bring-up, safety-critical design) plus regulatory fluency: IEC 62304 software lifecycle, IEC 60601-1, FDA 510(k)/PMA pathways, ISO 13485, and ISO 14971 risk management built into architecture — not added at the end.
Does Kyros handle the regulatory documentation too?
Yes. Kyros produces the design controls, DHF documentation, traceability, and V&V evidence a regulatory submission requires, alongside the firmware and electronics.
Do you work on IEC 62304 Class B and C software?
Yes. Kyros runs an IEC 62304-aware software lifecycle for Class B and Class C safety-critical embedded systems, with the rigor and documentation each class demands.
Who owns the source code and deliverables?
You do, fully: source, schematics, Gerbers, BOMs, and documentation, with a complete knowledge transfer. Kyros designs for clean handoff, not lock-in.
Do you take on embedded firmware and software development for diagnostic instruments?
Yes. Diagnostic instruments are our centre of gravity: low-noise analog front ends, precision timing, motion and fluidics control, and the verification evidence that has to survive an audit. As a contract engineering firm we work under your design controls, and the measurement chain gets treated as a system rather than as firmware bolted to a sensor.
Reduce your regulatory risk
Tell us about your device, pathway, and timeline. A principal engineer will walk through architecture, compliance, and how Kyros can compress your path to submission.
Talk to Our Founder