You know what should exist. Now build it.
Describe your clinical idea. Medflow Studio builds the working prototype — with the regulatory groundwork already started. No regulatory expertise required to begin.
Start with a sentence. Studio classifies it and starts the build — no regulatory expertise required to begin.
Clinical insight is everywhere. Turning it into regulated software is brutal.
You can see the fix your patients need. Between that insight and a real product sits a language built for large manufacturers — design control, IEC 62304, risk files — and most ideas die in the gap.
From prompt to product — and the record that comes with it.
Four plain-language steps. The regulatory checkpoints run underneath, surfaced only where your judgment is needed.
Describe the idea
Say it in plain words. Medflow classifies it — device or not, risk class, pathway.
Approve the design
It scopes requirements and lays out the architecture, summarised for your approval.
Generate the product
It generates a working, clickable prototype with a live, testable preview.
Export prototype + record
Export your prototype with a structured development record — needs, inputs, verification checks — yours to take with you.
A real product, not a promise.
Screens from the working product. A human reviews and approves at every checkpoint.
It places your idea on the map
Describe the idea and Studio classifies it — EU MDR and FDA class, the likely route to market, and the flags worth knowing early.
It builds a working, clickable prototype
A real, interactive prototype you can click through — with the decision-support guardrails built in, because it never replaces clinical judgment.
It structures the record you take with you
As you build, Studio assembles a structured development record — needs and design inputs traced to the standards — yours to export and carry into clinical validation.
Users come for the builder. They stay for the evidence.
Every tool builds software. Medflow's difference is what it builds alongside the software.
The builder
An AI-guided studio takes a clinical idea through classification, design, and a real build, in plain language. You leave with a working, clickable prototype.
The record
In the same visit, Medflow co-creates a structured development record — needs, inputs, and verification checks — built alongside the product. You export it and take it with you; it prepares your product to take forward into clinical validation.
Where it's going
Studio is designed to grow into a persistent workspace: take your record with you today, bring it home to Medflow tomorrow. Team workspaces and bring-your-own-key integrations are planned, not yet shipping.
The builder wins the first project. The record keeps every one after.
See your product before you pay a cent.
Per project — no subscriptionClassify your idea and see it built — both free. Pay only when you want to change it, keep it, and export the record that carries the value forward.
Device or not, risk class, pathway. Understand where you stand — no cost.
Describe your idea and watch your prototype appear. Clickable, on screen, in minutes.
Not quite right? Iterate until it is.
The full journey — the prototype, and the record generated alongside it.
Your structured development record: needs, inputs, and verification checks — yours to take with you.
Built by people who've done this before.
Twenty years of medical-device regulatory approvals, and engineering from Amazon, Microsoft, and Google.
Novo Nordisk, Ambu, Sanos Clinic. 20+ med-tech regulatory approvals. M.D., University of Copenhagen.
AudienceProject, Amazon, Microsoft, Google. PhD in Computer Science, University of Copenhagen.
AudienceProject, Nielsen, Valora. MSc, Aarhus University.
Straight answers.
Does Medflow Studio replace regulatory or clinical work?
What do I actually get at the end?
Does my work live in Medflow?
Do I need regulatory expertise to start?
Does Medflow Studio store patient data?
Is this a document generator or a consultancy?
Your idea deserves to exist.
Medflow Studio launches in October 2026. Join the waitlist for early access — and tell us what you'd build.
Join the waitlist