Venitara Evidence Engine
Evidence Ready
Risk, clinical, performance and engineering evidence
Every requirement that applies to your device, connected to the evidence you already hold, with the gaps named.
Where this sits
01Pathway
Ready
02Market
Ready
03Company
Ready
04Evidence
ReadyYou are here
05Submission
Ready
06Revenue
Ready
Your file, growing. Each stage begins with the work already in it.
Available at any stage
When to use Evidence Ready
Testing is under way, documents exist in several places, and nobody can say which requirement each one satisfies.
A Notified Body asks which requirement each piece of evidence answers. That mapping is usually what nobody has built, and it is not something you can assemble in the week before a submission.
What you receive
The Evidence Map
Each applicable requirement, the evidence you hold against it, and every gap that still has to be closed.
What it contains
The General Safety and Performance Requirements matrix, completed
The risk management file
The clinical evaluation plan
Labelling and instructions for use
The software file and cybersecurity documentation, where the device contains software
Every gap, named, with what closes it
What the work covers
| Document | Read against |
|---|---|
| General safety and performance requirements | MDR 2017/745, Annex I |
| Risk management file | ISO 14971 |
| Clinical evaluation plan | MDR Annex XIV, Part A |
| Usability engineering file | IEC 62366-1 |
| Software lifecycle file | IEC 62304 |
| Labelling and instructions for use | MDR Annex I, Chapter III |
| Biological evaluation | ISO 10993 |
For an in vitro diagnostic, the same work runs as an IVD edition, with performance evaluation in place of clinical evaluation.
Who does the work, and against what
The documents are generated from your own answers and stay consistent with each other as those answers change. A revision to the intended purpose reaches the risk file and the clinical evaluation plan without anyone remembering to carry it across.
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
A company with no regulatory hire can produce a complete technical file, and the team stays in the business it started.
You can see what you still have to generate before anyone asks you for it, which is the number that decides the evidence budget.
You also understand the technical file well enough to defend it, because you answered the questions it was built from.
The three levels for this product
Explore | Attest | Certify | |
|---|---|---|---|
| What you get | The evidence documents 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 to this product, document by document. Certification is wider. It assesses your quality management system and the regulatory operation alongside the complete technical file, so it covers the whole path rather than one product on it.
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
Generate evidence you do not have.
The map shows what exists and what does not. Testing, clinical investigation, and biological evaluation are performed by laboratories and investigators, not by a document.
Decide whether your evidence is sufficient.
A senior expert gives you a reading at Attest. Sufficiency is decided by your Notified Body.
Run your clinical investigation.
Where one is required, it is designed, sponsored, and run by you, under its own approvals.
Where this leads
Submission Ready.
With the map complete and the gaps closed, the technical file is read end to end against the criteria an assessor applies.
Diligence Ready.
The same evidence, written for an investor rather than an assessor, drawn from the technical file you already hold.
Common questions
What if the map shows large gaps?+
Then you have the number before anyone asks you for it, and you can decide what to fund and in what order. Finding out at submission removes that choice.
Is this an IVD product too?+
It runs as an IVD edition against IVDR 2017/746, with performance evaluation in place of clinical evaluation.
Do we own the documents?+
Yes, and you can export them at any point while the subscription is active.
How does this stay current when the product changes?+
Core information carries across the product record, so a change reaches every affected document rather than the one you remembered to open.
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