Question 1

What medical device standards do you design to?

Accepted Answer

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.

Question 2

Can you take a medical device from concept to submission-ready?

Accepted Answer

Yes. We cover firmware, electronics, and systems from architecture through verification, producing the documentation and traceability a regulatory submission requires.

Question 3

Who owns the IP and deliverables?

Accepted Answer

You own everything — source code, schematics, Gerbers, BOMs, and documentation. We do a full knowledge transfer and design for clean handoffs, not lock-in.