Walk into the next board meeting with a guaranteed FDA timeline.

Everything between your clinical intent and a clearance letter. Product and software engineering, AI/ML model development, quality system, regulatory strategy and submission, V&V, cybersecurity, human factors, risk management, and post-market. What is not in scope: your clinical trials, your wet lab, your sales force, and the things you would rather keep in-house. We map the line on the first call.

For the first call: a device concept, a sense of clinical intent, and any data or code you have already collected. That is enough. For the engagement itself, what ‘ready’ looks like depends on the device. For a 510(k) AI SaMD, you typically need a defensible training set, a held-out test set that reflects the intended use, and ground truth from qualified readers. If you are not there yet, we scope the data collection and curation work as the first phase. The first call exists to figure out where you actually are, which is usually different from where you think you are.

Yes, and we can come in regulatory-only. About a third of our engagements arrive that way: a working model, partial documentation, and an FDA pathway to figure out. We own regulatory strategy, V&V evidence, QMS gaps, cybersecurity dossier, the 510(k), and the FDA response from there, without rewriting code that already works. The clearance date guarantee still applies after the strategy sprint. (And if you want us to build the model from scratch, we do that too. AI Metrics and SmileDx both came in that way.)

You do, on both. Your regulatory lead signs the submission and remains the official sponsor contact. We draft, prepare you for the call, sit in on the meeting, and write the FDA responses. You own the source code (your repos), the model weights (your infrastructure), the design history file (your QMS), and the submission itself. We are the team that builds it. You are the sponsor.

Timeline: BodyCheck went idea-to-510(k) cleared in 12 months including the clinical study. AI Metrics was 18 months. GyriCalc was a similar magnitude. Regulatory-only engagements move faster: MedWeb was 7 weeks from kickoff to submission and 6 months to clearance because the software was already built and we owned the regulatory work end to end. If you are well-funded with training data ready, we can compress an end-to-end build to about 9 months.

Price: fixed-fee milestone pricing where we can scope cleanly; time-and-materials where scope is genuinely unknown.

Guarantee: for devices that pass the paid four-week strategy sprint, we put a clearance timeline and success guarantee in writing. The sprint exists for a reason. We will not commit to a date until we have looked at the data, predicates, and pathway closely enough to stand behind the number.

Yes. SimBioSys came to us with a hold letter; we found the response that landed the clearance without a new clinical study. Neosomas came to us with a monolithic first submission and wanted a better architecture; we designed one. Rescue engagements are Option B in the engagement models above.

When you want a binder of advice rather than a built product. When you need clinical trial operations or wet lab work, which we do not do. When the device is genuinely outside SaMD or SiMD, for example a hardware-first implant or a pure drug-device combination where the drug is the regulated article. And when the timeline is shorter than physics allows: we will tell you on the first call rather than take the engagement.