Venitara Launchpad
Revenue Ready
Reimbursement and launch planning for European markets
The reimbursement route for the market you are entering, and the post-market obligations that begin the day your certificate is issued.
Where this sits
01Pathway
Ready
02Market
Ready
03Company
Ready
04Evidence
Ready
05Submission
Ready
06Revenue
ReadyYou are here
Your file, growing. Each stage begins with the work already in it.
Available at any stage
When to use Revenue Ready
The regulatory pathway is settled and the commercial questions have turned urgent. A CE mark permits you to sell. It does not mean anyone has agreed to pay.
The obligations that start the day the certificate is issued are the other half of this. Post-market surveillance, vigilance, and periodic reporting all begin then, and they are cheaper to plan than to discover.
What you receive
The Reimbursement Dossier and the Go or No-Go Launch Checklist
The reimbursement case for your chosen market, the decision checklist that sits in front of launch, and the plan for what begins at certification.
What it contains
The reimbursement route and the evidence it expects
DiGA eligibility, where the product is a digital health application
The Go or No-Go launch checklist
The post-market surveillance and vigilance plan
What the work covers
| Document | Read against |
|---|---|
| Reimbursement case, Germany | SGB V, and the applicable DiGA or DiPA route |
| Reimbursement case, Switzerland | The Federal Office of Public Health listing routes |
| Post-market surveillance plan | MDR 2017/745, Article 84 |
| PMCF plan | MDR Annex XIV, Part B |
| Vigilance and incident reporting | MDR Articles 87 to 90 |
| Periodic safety update report | MDR Article 86 |
The same work runs for any EU market, against that market's own payer requirements and statutory deadlines.
Who does the work, and against what
The reimbursement route is assessed against the payer's own published requirements and statutory deadlines, in the market you have chosen.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects. The reimbursement work is delivered with HealthSeed AG, whose market access practice covers this ground.
What you can do with the result
You have a route to being paid alongside the route to being allowed to sell, and you know which of the two arrives first.
You can also start post-market surveillance on the day the certificate is issued rather than three months later, because the plan already exists.
The two levels for this product
Explore | Attest | |
|---|---|---|
| What you get | The reimbursement case and launch checklist built from your own answers | Each document read by a named senior expert and attested |
| Human review | No expert review | Reviewed by a named senior regulatory expert |
| What it may claim | An indicative working view | That this document was ready for submission on the date it was read |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document |
The Venitara Attestation records that a named senior regulatory expert has reviewed this document 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.
Scope and limits
Three things this product does not do
Negotiate your price.
The dossier makes the case. Pricing and reimbursement decisions sit with the payer.
Guarantee reimbursement.
Listing and reimbursement decisions are made by the payer or the responsible authority, on their own timelines.
Cover markets outside Europe.
European reimbursement is in scope. Routes elsewhere are scoped and quoted before work begins.
Where this leads
Fully Ready.
Post-market obligations do not end. Keeping the technical file current as the product and the evidence change is what the Living Technical File is for.
Diligence Ready.
A reimbursement route with evidence behind it is one of the few regulatory facts an investor can price.
Common questions
Can this start before we have a CE mark?+
Yes, and it usually should. The evidence a payer expects is not always the evidence a Notified Body expects, and finding that out after certification means generating some of it twice.
Is DiGA relevant to us?+
Only if the product is a digital health application meeting the German criteria. The eligibility question is answered as part of the work.
What about other EU markets?+
Every EU market is in scope. The work runs against that market's own payer requirements, and the route that applies is confirmed with you before it starts.
Who does the post-market work afterwards?+
You do, inside your quality system. Venitara builds the plan and can review what it produces.
Need an expert read before the technical file leaves your company?
If you are still working out where to begin, the free MedTech Compass takes about ten minutes.
Free · AI generated · 10 mins