A short pilot where our engineers design your device and build its regulatory paperwork at the same time — so nothing has to be reconstructed later.
Take the design, the documentation, or both.
60 minutes · No deck · Free
We design your device three ways, so the best idea wins — not just the first.
The strongest concept built into a single ready-to-build prototype.
Proven on the bench and with FEA before you commit to launch.
Complete the day the prototype is finished. Nothing to reconstruct.
You build for months — designing, changing, fixing, until the prototype finally works.
Then the FDA asks for proof: “show us the record of every design decision, risk and test.”
But nothing was written down — it lives in old emails and people's memories.
So the submission gets rejected, and your timeline slips while you rebuild a history you never recorded.
The NPD Sprint makes sure this never happens to you.
A surgical instrument, designed right the first time with the 3-Concept Method.
Taken out before it was locked in — because decisions were made on evidence.
Device teams across the US, India and Ireland on the same ISO 13485 framework.
Every figure above is a real, anonymised SolidPro project. Nothing here is aspirational.
A device already selling in the market. For that, ask us about a Cost-Down Teardown instead.
Self-score your design-controls readiness in a few minutes, in your browser. You instantly see your gaps — and we can turn it into an honest snapshot of what a reviewer would flag today.
60 minutes, no deck, no pitch. We tell you straight whether we can help and what the Sprint would cover for your device.
A short, low-risk pilot on your real device. You finish with the design, the documentation, or both — plus a clear findings list and a recommended next step.
A straight answer about whether we can help. No deck, no pitch.
No meeting is booked automatically.
Built for startups and first-device teams working to 21 CFR 820.30 and ISO 13485 §7.3.
60 minutes, no deck, no pitch. We tell you straight whether we can help.
No meeting is booked automatically.