Regulated and compliant platforms

FDA and CE compliant, through an $80M Series C

Regulated software is not ordinary software with extra paperwork. The constraints shape the product, and teams that treat compliance as a final gate tend to discover that late and expensively.

Design that survives review

In a regulated build, the question is never only whether something works. It is whether you can show how it works, why it was built that way, what you tested and what happens when it fails. That record is easier to produce when the product was designed with it in mind.

We work the constraints in early: risk, traceability, failure states, the human factors that reviewers ask about. It makes for slower first drafts and considerably faster approvals.

Real time, real stakes

Some of this work is live. An operating room, a trading floor, an incident response. The software has to be legible under pressure by someone who has no attention to spare for it, and it has to behave predictably when the network does not.

That changes the design brief. Fewer choices on screen, clearer system states, latency you can see rather than guess at, and recovery that does not punish the user for a dropped connection.

Where this comes from

Product strategy and design leadership for real-time surgical collaboration and operating-room software, built to clinical and regulatory standards, FDA and CE compliant, through an $80M Series C. Related experience in financial data products where regulators, auditors and risk functions all have a say.

Do you handle the regulatory submission itself?
No. Your regulatory lead or consultant owns the submission. We make sure the product is designed so the evidence they need exists, which is where most delays come from.
Is regulated work always slower?
The first drafts are slower because the constraints go in early. Approval is usually faster, because there is less to unpick. Teams that leave compliance to the end generally pay the difference back with interest.
Which standards have you worked to?
FDA and CE for clinical software, and the audit and risk requirements that come with regulated financial data. The approach transfers to other regimes, though the specifics always need your regulatory lead.

Talk to us about this kind of work.

Tell us what you are building and what makes it hard. A short note is plenty, and it comes straight to Juan and Andrew.

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