Human-led regulatory clarity for MedTech and HealthTech founders.
Know your device class, route to market, and regulatory gaps.
Regulation gets overwhelming fast. Venitara turns it into clear next steps: senior experts own the decisions that carry real risk, AI does the groundwork, and you can start free.
40+ projects delivered · EU · US · MENA · Assessor-grade review
Inside the dossier.
One guided tool at a time. AI drafts, you decide, the file grows.
AssessmentToolsDossierStart free assessmentContinuous glucose monitor
Not started
- Set your target market
- Run classification
- Complete your dossier
- Get expert review
Your dossier
Facts resolve here as tools complete, and your expert validates them.
What first submissions are up against.
Getting the file wrong is the expensive part.
~64%
of 510(k) submissions face rejection at some stage
12–18 months
typical CE marking timeline for Class IIa software
EUR 120–300k
commonly cited cost to CE mark a software device
2026–2027
EU AI Act obligations reach AI-enabled devices
Most of that lost time traces to one root: a classification or file that was wrong before the build began. See where your file stands →
Published industry figures, source-attributed in Resources. Market benchmarks, not Venitara performance claims. AI Act dates are subject to the EU Digital Omnibus.
One path, three levels of assurance.
Start free, add human judgement as the stakes rise.
01
Explore
Free. Answer a guided set of questions and get an AI-generated view of your likely device class, route to market, and the gaps to close next. No cost, no commitment, no human review yet.
Start free →02
Validate
When the decision matters, a senior regulatory expert reviews your file against the assessor standard, checks the AI outputs, and shows you what holds and what needs work.
Talk to an expert →03
Attest
When you are preparing for serious review, we build and lead the work to a submission-ready standard. The Venitara Attestation is an expert-backed confirmation of readiness before your file moves toward Notified Body review.
The Venitara Attestation is an independent submission-readiness attestation, not a Notified Body endorsement or a guarantee of approval.
See how we attest →Wherever you are, there is a next step.
Start with the free MedTech Compass to understand what you need now. Then move from AI-guided clarity to expert validation and submission-ready support as your company grows.
01
Assess and Position
Clarify your device class, route to market, priority markets, and key regulatory gaps so you can make your next product and launch decisions with more confidence.
Explore your regulatory path
02
Build the evidence
Structure your technical file, clinical evidence, and quality documentation around what reviewers will expect so your product is easier to assess, defend, and move forward.
Build your evidence plan
03
Quality and compliance
Set up the processes, records, and routines your product needs so quality becomes part of how your company operates, not a last-minute audit scramble.
Build your quality system
04
Launch, fund, and govern
Build the lifecycle strategy, investor-ready validation, and market pathway your product needs to launch, scale, and create commercial value.
Explore launch support
Data and AI governance for every journey.
Add EU AI Act, GDPR, and AI workflow governance support to any package. We help you put the right controls, documentation, and human oversight in place so data and AI support your product instead of slowing it down.
Explore the governance trackIn practice
A better file starts with a founder who understands it.
A founder came to us with a technical file they had inherited from another vendor. They believed they were building a Class IIa device, but the intended use, classification, and documentation were not clear enough to defend with confidence.
We worked through the product with them, not around them. Together, we clarified the intended use, refined the classification, and rebuilt the file around what mattered.
They did not end up with a bigger file. They ended up with the right one, and the vocabulary to own it.
AI-supported speed. Human expert judgement. Independent assessment.
VENITARA uses AI to structure the work, experienced experts to review the decisions, and independent assessment to give founders clearer confidence in the result.
Swipe sideways to compare all columns.
VENITARA Humans plus governed AI, one team | AI-only tools Chatbots, copilots, auto-generated files | Template packs Downloadable QMS and TD templates | Traditional consultancy Senior humans, on retainer | |
|---|---|---|---|---|
A human owns the call on your classification and risk Someone whose name is on the outcome, not just an output. | – | – | ||
You can start today without a scoping call or retainer Free MedTech Compass, self-serve entry, no gatekeeping. | – | |||
Adapts to your product, not a generic template Your evidence, your intended use, your gaps, in your words. | – | |||
A written attestation you can put in front of a Notified Body Not a dashboard score, not a PDF export from a template pack. | – | – | ||
One team across EU, US and MENA, including AI governance One conversation instead of three vendors and a translator. | – | – | – |
Three lines of defence behind every attested file.
01
In-build controls
Quality is built in at the point of creation: structured fields, cited determinations, and automated consistency checks across the file.
02
Independent internal audit
Internal Quality Controls, Independent Audit, Notified Body
03
Notified Body cooperation
We help structure your file around the Notified Body pathway, evidence expectations, and review workflow your product needs to be ready for.
See where you stand, in about ten minutes.
Free, AI-powered, and every gap comes with a next step.