Our pricing
Venitara offers affordable solutions at every stage of the regulatory processes.
Four ways in
Start free. Add what you need, when you need it.
MedTech Compass
See where you stand, and what to close next.
Free
Ten minutes. No card.
Start nowPlatform subscription
The tools, the documents, and your product record.
€349
Per month. Cancel any time.
See what is includedSpeak to a consultant
A senior regulatory expert reviews your situation and tells you what to close first.
€250
Per hour. Book a single call.
Book a callExpert support
A named senior expert on the parts that carry risk.
from €4,600
Per stage.
See the stagesEverything you complete carries forward, so moving from one to the next starts with the work already in your file.
Free · AI generated · 10 mins
Prices are in euros and exclude VAT. Everything priced here is EU MDR, Class IIa reference.
Choose what you need
Three ways in. Pick the one that matches where the file is now.
You are building the file yourself, and it has to hold together.
The workspace
One product record, 57 validated tools and 130 documents. Everything stays consistent as the device changes.
€349 per month, or €3,799 per year
You know which parts of the file carry the risk.
The four stages
A named senior expert reads each deliverable and records what holds and what does not. Bought a stage at a time.
from €4,600 per stage
You inherited a file, or the route runs outside the EU.
Scoped regulatory work
Work outside the EU MDR path, including FDA and Gulf submissions, or a file that needs completing before assessment.
Quoted before work begins
Each one can be bought on its own. The sections below show exactly what the price covers.
Why the work is priced separately
Pay for expert time where it earns its place
The workspace carries structured capture and drafting across the file. Expert review is bought a stage at a time, covering the deliverables that matter at that point in the file.
Keeping those forms of work separate gives you control over the spend and keeps the review status clear. Every output states whether it is a working draft or an attested deliverable.
The workspace
Build and maintain the working file
One subscription gives your team a controlled product record and the working regulatory documents built from it.
€349
per device per month
Pay month by month under the published subscription terms.
Annual €3,799 per device per year
Included in the workspace
Output at this level is AI-generated and marked as unreviewed. Expert review is bought separately.
What one subscription covers
One device means one product record.
The product record holds
Core information carries across the record, so the file is never reconstructed for a new document.
Raising a document
Add review later, without rebuilding.
Choose the documents that need it. The rest stay as they are.
The path to submission
Four stages, bought as you reach them
Each stage covers the deliverables that matter at that point in the file. Buy them one at a time, or take the whole path at once.
Stage 1
Base camp
What the device is, and what that obliges you to do
€4,600
Per stage.
Deliverables
Stage 2
Foundations
The quality system and the safety spine
€14,600
Per stage.
Deliverables
Stage 3
Evidence
The reports that prove it
€18,500
Per stage.
Deliverables
Stage 4
Submission Ready
Assembly, cross-checks, and the application pack
€12,300
Per stage.
Deliverables
The four stages together
Bought one stage at a time, at the published stage prices.
€50,000
The Venitara Attestation
The Venitara Attestation records that a named senior regulatory expert has reviewed this deliverable against the Venitara rubric, confirming concordance with the applicable regulatory requirements and assessing it as ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Two ways to buy
Take the stages as you reach them, or the whole path at once
Every reviewed deliverable carries the Venitara Attestation either way. Certify adds the assessment of your quality system and the Certificate that goes with it.
What you are buying
Attest
A stage at a time
Certify
The whole path, one engagement
Stage 1 · Base camp
€4,600
runs to €4,600
Included
Stage 2 · Foundations
€14,600
runs to €19,200
Included
Stage 3 · Evidence
€18,500
runs to €37,700
Included
Stage 4 · Submission Ready
€12,300
runs to €50,000
Included
Platform, 24 months
€8,376
runs to €58,376
Included
Assessment of the quality system
Not included
Included
Attestation seal on every reviewed deliverable
Yes
Yes
The Certificate
No
Yes
Total
€58,376
€49,000
Already taken the stages? The Certificate can be added afterwards for €9,000. Prices are in euros and exclude VAT. Notified Body and regulator fees are separate and paid directly by you.
What Certify includes
One engagement, from the first determination to the Certificate
Certify covers the whole EU MDR path for one device, and the system around it.
Included
The four stages
Every deliverable in Base camp, Foundations, Evidence, and Submission Ready, each read by a named senior expert and attested.
Included
Assessment of the quality system
Senior regulatory experts assess the quality management system and the regulatory operation around it, not only the documents inside it.
Included
The Certificate
Venitara Certification issues as a Certificate stating the company, the scope assessed, the date, and the rubric version.
Included
Two years of platform
Twenty-four months of the workspace for the device, so the record stays live through the engagement and after it.
Venitara Certification
Venitara Certification records an independent assessment of this organisation's regulatory system and technical documentation, performed by senior regulatory experts, confirming concordance with the applicable regulatory requirements and stating that the system is ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
What this costs elsewhere
A published price, against a range nobody can tell you in advance
European regulatory consultancy is quoted as a band or billed by the hour. The two Venitara figures are the figures.
Class IIa, EU MDR, consulting scope. Notified Body fees excluded from every figure.
Venitara Certify
€49,000
Venitara Attest
€58,376
Fixed-price EU consultancy
€50,000 to €70,000
Hourly EU consultancy, 12 months or more
€100,000 to €150,000
Charges Venitara does not add
No software charges hiding behind the headline price
Download your work at any point while the subscription is active, and export the file before it ends. Everything you have downloaded stays yours.
Free, and it stays free
Start by finding out where you stand
The MedTech Compass takes about ten minutes and gives you an indicative view of how your product is likely to be regulated and what you already have in place. There is no call, payment card, or obligation.
Questions about the price list
The questions that come up most
We have two devices. Do we pay twice?
Each device has its own product record and classification, supported by a separate technical file. Each therefore carries its own subscription. If you have a portfolio of devices, Venitara will define the records and total scope before you commit.
Are workspace documents reviewed by an expert?
Workspace outputs are working documents at Explore level. They are clearly marked as not expert-reviewed and not suitable for submission. Attest adds named expert review and dated findings to the deliverables you select.
What happens if we stop the subscription?
You can export your documents before the subscription ends, and everything you have already downloaded remains yours. Access to the workspace itself ends with the subscription.
Can we buy expert review without a subscription?
Each stage is priced separately and can be bought without a subscription. If a deliverable already exists, Venitara reviews the version you provide.
Do we have to take the stages in order?
Most files move through them in sequence, because each stage assumes the one before it. You can buy any stage on its own if the earlier work is already in place.
Can Venitara assess a file built somewhere else?
Certify can assess a file built by your team or another provider. The Certificate identifies the reviewer and date, together with the assessment scope and the document versions covered.
What determines the price of completion work?
The quote depends on the file inventory, device class, document condition, unresolved evidence, and markets in scope. Venitara provides the written scope, assumptions, dependencies, and price before work begins.
Are the published prices final?
The prices shown apply to the listed scope. Work whose scope varies is quoted before it begins.
Does Venitara Certification mean the file will be approved?
Certification records Venitara's assessment of submission readiness at a defined point in time. Decisions on certification, clearance, approval, or market authorisation remain with the relevant Notified Body or regulator.
Not sure which applies?
Run the Compass first. It tells you which of these actually applies to your device before you spend anything.
Free · AI generated · 10 mins
Question not here? Ask a regulatory expert.
Start with the work you need now.
Use the free Compass if you are still establishing the route. Choose the workspace if your team is ready to build, or take the stages as you reach them.