Question 1

What should I look for in a medical device firmware consultant?

Accepted Answer

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.

Question 2

Does Kyros handle the regulatory documentation too?

Accepted Answer

Yes. Kyros produces the design controls, DHF documentation, traceability, and V&V evidence a regulatory submission requires, alongside the firmware and electronics.

Question 3

IEC 62304 Class B and C software?

Accepted Answer

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.

Question 4

Who owns the source code and deliverables?

Accepted Answer

You do, fully: source, schematics, Gerbers, BOMs, and documentation, with a complete knowledge transfer. Kyros designs for clean handoff, not lock-in.