Venitara Complete
Fully Ready
One regulatory system from idea through lifecycle
Every Venitara product in one subscription, with a technical file that stays current as the product, the evidence, and the obligations change.
Where this sits
Your file, growing. Each stage begins with the work already in it.
Available at any stage
Diligence Ready
Fully ReadyWhen to use Fully Ready
You already know you are going the whole way, and you would rather make one decision than the same procurement decision six times over three years.
Buying products one at a time also means each one starts from the last one's output. Here the file is continuous, so nothing is rebuilt to hand it on.
What you receive
The Living Technical File
Every Venitara product, working on one product record, kept current as the device and its obligations change.
What it contains
Every product in the catalogue, from classification through post-market
One product record, carrying information across every document
The technical file kept current rather than rebuilt when something changes
Priority access to Venitara's regulatory experts
What the subscription covers
| Product | What it covers |
|---|---|
| Pathway Ready | Classification, intended purpose, and the route |
| Market Ready | The launch order, and what each market expects |
| Company Ready | The quality system, sized to the team |
| Evidence Ready | Every requirement, and the evidence against it |
| Submission Ready | The complete technical file, read against the criteria an assessor applies |
| Revenue Ready | Reimbursement, launch, and the obligations that begin at certification |
| Diligence Ready | The regulatory position, written for an investor |
Who does the work, and against what
The same named senior regulatory experts, working on one product record rather than seven engagements. Every answer feeds the next document, so the second year begins with the first year's work rather than a handover.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects.
What you can do with the result
Regulatory spend sits on one line in the budget rather than arriving as a series of unbudgeted decisions.
The technical file is current on any day an investor, an auditor, or an acquirer asks to see it, rather than assembled in the fortnight after they ask.
And the team works to a rhythm. Regulation stops being the thing that interrupts everything else every few months.
The three levels for this product
Explore | Attest | Certify | |
|---|---|---|---|
| What you get | Every document built from your own answers | Each selected document read by a named senior expert and attested | The quality system and the complete technical file independently assessed |
| Human review | No expert review | Reviewed by a named senior regulatory expert | Assessed by senior regulatory experts who did not write the documents |
| What it may claim | An indicative working view | That this document was ready for submission on the date it was read | That the system was ready for submission on the date it was assessed |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document | The Certification seal, on the certificate |
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.
Where Certification fits
Attest applies across every document in the subscription. Certification is the assessment of the system that holds them. It reads your quality management system and the regulatory operation alongside the complete technical file, and issues as a Certificate.
Certification issues as a Certificate, and it includes an Attestation on every document inside the scope assessed.
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.
Scope and limits
Three things this product does not do
Take responsibility for your technical file.
You remain the manufacturer. The decisions stay yours, and what changes is that you are not making them blind.
Cover markets outside the published scope.
The EU route is covered. United States and Gulf submissions are scoped and quoted before work begins.
Continue after the subscription ends.
You can export everything, and what you have downloaded stays yours. The workspace itself ends with the subscription.
Where this leads
Nowhere else.
This is the whole catalogue. What continues is the file, through each product change, each new market, and each post-market cycle.
Common questions
Can we start here?+
Yes, and most companies do not. Fully Ready suits a company that already knows the route it is taking. If you do not yet, start with the free MedTech Compass or Pathway Ready.
We have two devices. Does one subscription cover both?+
No. Each device has its own product record and its own technical file, so each carries its own subscription. A portfolio is scoped before you commit.
Can we move to this later?+
Yes. Everything you have already completed carries forward, so the work already done is the work you start from.
What happens when the regulation changes?+
The technical file is kept current rather than rebuilt. Where a change affects a document a named expert has attested, you are told which documents it reaches.
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