Question 1

Can you work under our quality management system?

Accepted Answer

Yes. We execute inside your ISO 13485 QMS and design-control procedures, or help early-stage teams stand up right-sized design controls before their first design review.

Question 2

Do you handle FDA 510(k) submissions?

Accepted Answer

We deliver the engineering substance of a submission — architecture, risk files, requirements traceability, and V&V evidence — and work alongside your regulatory consultant who owns the filing itself. The engineering documentation arrives submission-ready.

Question 3

Can you help before we're under design controls?

Accepted Answer

Yes — feasibility and works-like prototypes are often the right first step. We architect them so the path into design controls is clean, rather than forcing a rebuild when the project formalizes.

Question 4

What does a medical device engagement cost?

Accepted Answer

Engagements start with a $6K fixed-price Architecture Diagnostic that de-risks the technical and regulatory path. Device development programs are milestone-gated and scale with device class, typically from $75K for focused subsystems upward.