Question 1

Do you handle regulatory and compliance (FDA, IEC 60601)?

Accepted Answer

Yes — we design for it from day one. We have deep experience with IEC 60601-1, FDA 510(k)/PMA/De Novo, ISO 13485, and ISO 14971 risk management, built into architecture decisions.

Question 2

Can you work with our existing team or do you need full ownership?

Accepted Answer

Both. We can embed as an extension of your team filling a specific gap, or own an entire workstream end-to-end. Most clients start with a focused sprint and expand.

Question 3

Do you do mechanical engineering and industrial design too?

Accepted Answer

Our core team covers electrical, firmware, PCB, and system architecture. For mechanical and industrial design we have a vetted extended network — one team, one point of contact.