Independent certification lab for AI in medical devices
AI is now inside regulated medical devices — diagnosing, triaging, adapting — whether embedded in hardware or as software that is the device (SaMD). creiamo.ai verifies that the AI does what its technical file claims, and keeps proving it after the certificate issues. Independent, continuous, and on the record.
We find the gaps before your notified body does — then we keep watching.
Probabilistic AI breaks deterministic conformity assessment.
Any company shipping AI inside a regulated device in Europe faces two costs. Getting the technical file through conformity assessment — typically 9 to 24 months, per Team-NB, the European association of notified bodies* — and most files arrive substantially incomplete. And proving the AI still behaves as certified once it's live — a post-market obligation regulators have made explicit for adaptive AI. We build the evidence layer for both.
Deterministic software
Same input, same output. Test once, sign off, ship. The assurance holds because the system cannot surprise you.
Probabilistic systems
Novel outputs from identical inputs, and behaviour that evolves after deployment. The AI-specific evidence — robustness, drift, evaluation — is the newest part of the file, and the part reviewers question most.
* Team-NB, Medical Device Survey 2025 · team-nb.org
Find the deficiency letter before your notified body writes it.
A scoped 8–12 week engagement on one device, one regulatory route. Three steps, each leaving evidence you hold whether or not we ever work together again.
Gap assessment
Your technical documentation assessed against the AI-specific requirements inside the conformity procedure. Every finding named, versioned, and traceable — ready for your team to close.
Submission-ready evidence
Robustness testing, drift characterisation, evaluation documentation — test protocols, results, and write-ups produced under stress and edge-case conditions, written into your risk management file and technical documentation, in your format.
Live post-market stream
The device is instrumented during the engagement, so PMS, PMCF and PSUR inputs flow from the day the certificate issues — not retrofitted onto a certified device under change control.
Work with us directly, or alongside the regulatory consultants you already trust — the evidence lands in your technical file, in your format, either way.
creiamo.ai is an independent laboratory for AI in medical devices. We are not a notified body and we issue no certificates — conformity assessment remains with your notified body. We produce the evidence it assesses.
Two ways to start.
Certification readiness
For devices heading to CE marking or FDA clearance. A gap assessment of your technical documentation against the AI-specific requirements by week 4; submission-ready evidence — robustness testing, drift characterisation, evaluation documentation — written into your file, in your format, by week 12. Work with us directly or alongside your consultants. Your notified body and your timeline stay exactly as they are.
Monitoring first
For devices on the market. We instrument the device and your PMS, PMCF and PSUR inputs flow from a live evidence stream — instead of being retrofitted onto a certified device under change control. As the device is updated or taken to new markets, the certification evidence stays current.
Either path can begin in the Founding Partners Program. Both leave evidence you hold.
Where we work.
We start where the obligation is statutory and the queue is longest: EU MDR and IVDR, with the AI Act requirements assessed inside the same conformity procedure. We also build FDA-facing evidence for US regulatory routes.
Filing somewhere else — the UK, Switzerland, or another market that recognises EU or US evidence? Tell us your route when you write. It won't change what you receive; it will shape what we prioritise next.
For regulatory consultants.
The AI sections of the technical file are the newest part of your clients' submissions — and the part a template can't produce. Robustness testing, drift characterisation, evaluation documentation: laboratory work, not paperwork.
Use creiamo.ai as the lab behind your practice. You keep the client, the file and the relationship; we produce the AI-specific evidence to your scope, in your client's format, under your review — and we never sit on your critical path. One client device is enough to start, on the same founding terms.
Request a scoping call — bring the device, we'll bring the evidence plan.
Medical devices first — deliberately.
The technology underneath — testing AI against its declared behaviour and generating regulator-grade evidence, continuously — isn't specific to medicine. It applies to any AI operating under a regulatory duty to prove itself. We start where the obligation is statutory, the assessment bottleneck is most acute, and the bar is highest: the hardest proving ground, and the beachhead for every regulated sector after it.
The obligation to prove AI behaviour is spreading faster than the capacity to assess it. We build the evidence layer once — the regulated world reuses it.
Trust that is signed, dated, and accountable.
We never say "trust us." We show the evidence — every claim links to something verifiable.
We build
- Certification evidence
- Continuous monitoring
- Reliability ratings
For
- AI / SaMD manufacturers
- Notified bodies & regulators
- Insurers & investors
Across
- Medical devices — now
- Other regulated sectors — to come
Frequently asked questions.
Is creiamo.ai a notified body?
Does creiamo.ai cover software as a medical device (SaMD)?
Can regulatory consultants use creiamo.ai for their clients?
Which markets does creiamo.ai work in?
Do notified bodies or authorities work with creiamo.ai?
Hold the evidence before the review begins.
For companies with an AI-enabled device — physical or SaMD — heading toward — or already holding — CE marking or FDA clearance. Paid at a discounted founding fee, fully credited against the first-year service if you continue.
wk 12 submission-ready AI evidence, in your format
day 1 post-market monitoring live from certificate issue
Investor, or want to introduce a portfolio company? Same address — hello@creiamo.ai.