VENITARA PROGRAMME PARTNERSHIP
Give your MedTech teams a regulatory head start
Partner with Venitara and every eligible MedTech, IVD, SaMD and digital health team in your accelerator, incubator or hackathon gets a month on the Venitara platform. Your winners get time with a senior regulatory expert. There is no cost to your programme.
FOR YOUR WINNERS
UP TO 5 HOURS
of senior regulatory expert time, worth EUR 1,500.
You decide how the hours are shared. One winner can take all five, or five winners can take one hour each.
Applications are read by a person. There is no joining fee and no minimum cohort size.
Vera
The senior regulatory experts behind Venitara, there when a decision needs human judgement.
VI
The AI that does the groundwork, mapping class, route, and gaps from each team’s own answers.
WHY THIS EXISTS
Most programmes have no regulatory expert on the team.
A MedTech team can win a hackathon, finish an accelerator and still not know whether their product is a medical device, which class it falls into, or what the route to market costs. That question decides their timeline and their budget, and it usually arrives too late to answer cheaply.
Hiring a regulatory expert for a cohort is not practical. Mentor hours are scarce and rarely regulatory. This partnership puts a structured regulatory starting point in front of every eligible team in your programme, and senior expert time in front of the teams that win.
HOW IT WORKS
Four steps, and the first one takes ten minutes.
01
Apply
Tell us about your programme, your dates and how many MedTech teams you expect.
02
Agree the cohort
We confirm which teams are eligible, when their month starts, and how the expert hours will be awarded.
03
Teams get their month
Every eligible team gets access to the Venitara platform for one month and works through their regulatory position at their own pace.
04
Winners take the expert hours
Your winners book their share of the five hours with a senior regulatory expert, within the agreed window.
WHAT YOUR TEAMS GET
One month on the Venitara platform.
Teams map their likely device class, their route to market, and the gaps between what they have and what a submission needs, across the EU, the United States and selected MENA markets.
Classification
Indicative EU MDR and IVDR classification with the rule behind it, plus indicative software classification for SaMD.
Intended purpose
Device basics and a detailed intended-purpose file, written in the form a submission needs.
Responsibilities
Readiness for the Person Responsible for Regulatory Compliance, company registration, insurance and roles.
Route to market
Target markets, FDA market entry, MENA considerations, and a regulatory roadmap that pulls the inputs together.
Platform outputs at this level are AI-generated and not validated by an expert.
FOR YOUR PROGRAMME
Regulatory depth you do not have to hire.
A regulatory prize to award.
Five hours with a senior regulatory expert is something most programmes cannot offer their winners.
Better-prepared teams.
Teams reach demo day able to state their indicative class, their route to market and their gaps.
No cost and little admin.
We set up access for your cohort and handle the onboarding.
The experts behind Venitara bring more than forty regulatory projects and work involving ten to twelve Notified Bodies.
FIT
Built for programmes with health innovators in them.
A good fit
- Accelerators, incubators, university spin-out programmes and hackathons in Europe.
- At least one MedTech, IVD, SaMD or digital health team in the cohort.
- A named person who can confirm eligible teams and the award of expert hours.
- Willing to describe what Venitara does accurately to participants.
Not a fit
- Programmes with no health or life science teams.
- Requests to resell or bundle the offer as a paid benefit.
- Anyone willing to promise regulatory outcomes or approvals on Venitara’s behalf.
QUESTIONS
The ones a programme manager asks first.
Bring Venitara into your next cohort.
Tell us about your programme and your dates. We will confirm eligibility, set up access for your teams, and agree how the expert hours are awarded before your programme starts.
Apply to become a programme partnerNo joining fee. Approval does not make your programme an agent or an exclusive partner of Venitara.