Regulatory platform: AI regulatory tools with expert review
Reach CE marking faster, with an expert's name on the file.
Your complete regulatory system, AI automated with human expert oversight, from intended purpose to file submission, for medical device, SaMD and IVD companies.
regulatory tools
documents
EU · US · MENA
The AI does the groundwork.Drafting, gap-finding, and keeping the file consistent.
A senior human expert does the validation.Classification, intended purpose, and clinical evaluation.
Free · AI generated · 10 mins
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.
Where regulatory submissions fail
Getting the regulatory submission file wrong due to a lack of expert knowledge in the process
~64%
of 510(k) submissions face rejection at some stage
12–18 months
typical CE marking timeline for Class IIa software
€120–300k
commonly cited cost to CE mark a software device
2028
EU AI Act obligations reach AI-enabled devices
Misclassification and a lack of evidence are the key reasons for regulatory rejections. These are costly mistakes. Even with validated AI systems, the errors come from the founder not describing their solution properly.
At Venitara, we help to remove the risk of regulatory submission failure by validating AI outputs with affordable human expert advice.
Published industry figures describing the market, source-attributed in Resources. AI Act dates are subject to the EU Digital Omnibus.
Where Venitara can help you
Accelerate your path to market
AI for the speed. A senior expert for the assurance.
You always know where your file actually stands.
Everywhere else you find out when someone else tells you. Usually it's your Notified Body, months in, when fixing it costs the most.
Guided from the first question
The tools ask in plain language what your product does and who uses it, then build the document from your answers. Every part says whether a regulatory expert has looked at it, and when, so you can see which sections are solid and which are still a first draft.
What you get instead
AI tools hand you finished-looking text with no way to tell if it holds up. A template stays blank until you fill it in.
An expert on the parts that worry you
Some decisions carry real consequences and most do not. Put a named senior expert on the ones that do, leave the rest, and come back when your product changes.
What you get instead
Consultants sell days, or a whole project with the scope agreed up front. Buying an hour on the one document keeping you up at night is often off the table.
Get it signed before it counts
When the work is done, the senior expert who reviewed it puts their name to a written statement saying so. Show it to an investor. Take it into your review.
What you get instead
AI will not sign anything, and a template cannot. Most consultants give you advice, which stays advice.
Expert review without a subscription
Bring a file your own team or another provider built. A senior expert reviews it and attests what is ready, with no requirement to move your work onto the platform first.
What you get instead
Most platforms make the subscription the entry condition. Most consultancies want the whole project before they will look at one document.
The Venitara Attestation is an independent submission-readiness attestation, not a Notified Body endorsement or a guarantee of approval.
The Venitara advantage
Start at the stage you are at.
8
Products, one for every stage from intended purpose to market.
57
Validated regulatory tools doing the analytical work underneath.
130
Regulatory documents, written and ready to adapt to your device.
Venitara supports your entire regulatory journey.
Your file lives in one workspace built for your device. Each stage starts from the work already in it, so nothing gets re-entered and nothing contradicts itself later.
The regulatory sequence
Available at any point on the route
Stage 01 · Define the product and the market
Venitara Preparation
Pathway Ready
Know exactly how your product is regulated, before you design around it.
The Regulatory Roadmap: classification, applicable rule, pathway and milestones.
Get your classificationUse this when
You have a product and no regulatory position yet
See all eight products, side by side
The Venitara Attestation is an independent submission-readiness attestation, not a Notified Body endorsement or a guarantee of approval.
Data and AI governance, on any product.
Add EU AI Act, GDPR and AI workflow governance to any package. We help you put the right controls, documentation and human oversight in place so data and AI move your product forward.
Explore the governance trackOne path, three levels of assurance
Start free, add human judgement as the stakes rise.
AI can be wrong, and regulatory is where that matters most. So every output tells you what it is. It is the same file at each level, and you raise it when the decision starts to carry consequences.
Intended purpose
Continuous measurement of interstitial glucose in adults with type 1 diabetes for the purpose of therapy adjustment under clinical supervision.
Applicable rule
Annex VIII, Rule 11. Software intended to provide information used to take decisions with diagnostic or therapeutic purposes.
Classification
Class IIa. Conformity assessment under Annex IX Chapter I and III.
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. Every output is marked as AI-generated until an expert reviews it.
02
Attest
When the decision matters, a senior regulatory expert reviews your file, checks the AI outputs, and shows you what holds and what needs work.
03
Certify
When you are preparing for serious review, senior experts who did not write your documents assess your regulatory system and your complete technical file. The Venitara Certificate records submission readiness within the assessed scope, on a stated date.
The Venitara Attestation is an independent submission-readiness attestation, not a Notified Body endorsement or a guarantee of approval.
In 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, and the intended use, classification and documentation needed to be clear enough to defend.
We worked through the product with them, decision by decision. Together, we clarified the intended use, refined the classification and rebuilt the file around what mattered.
They ended up with the right file, and the vocabulary to own it.
Anonymised.
What changed
- Classification re-scoped after intended-use review
- Technical documentation rebuilt around the actual product
- Founder able to explain and defend the file with confidence
AI-supported speed. Human expert judgement. Independent assessment.
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
Work is reviewed by a second senior expert, independent of whoever authored it, against the standard an assessor applies.
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.
You get your likely device class, your route to market, and every gap that stands between them, each one with a next step. Then you decide how much of it you want an expert to look at.
Free · AI generated · 10 mins