The Venitara assurance model
What attestation and certification mean here
Three levels of assurance, and two written records an investor or an assessor can check.
Request a file readiness reviewWhat attested means
What an attestation records
Regulatory documents can look complete before anyone with the right experience has read them. An assessor, an investor, or a buyer will ask who checked the work and what they checked it against.
Venitara Attestation
Sample. Redacted.
Reviewed
Clinical evaluation report, version 2.1
Against
MDR 2017/745, Annex XIV
By
A. Reviewer, Senior Regulatory Expert
On
14 March 2026
Rubric
Venitara rubric v4.2
Venitara decides
Whether your file is ready to submit.
A senior expert reads the file, assesses it against the requirements that apply to your device, and records what they found.
Your Notified Body decides
Whether your device is approved.
Approval is a decision taken by a Notified Body or a competent authority. No one outside those bodies can give it to you or promise it.
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.
The three levels
Explore | Attest | Certify | |
|---|---|---|---|
| What you get | A working document built from your own answers | The document reviewed and attested, with dated findings | The system and the complete file assessed, and the certificate issued |
| 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 |
| Never claims | Suitability for submission | Anything about documents outside the review | Conformity, certification, clearance, approval, or a Notified Body decision |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document | The Certification seal, on the certificate |
| How you get in | The free MedTech Compass, or the platform subscription | A stage at a time | The whole path, one engagement |
You can raise a document from Explore to Attest without starting again. Certification includes an attestation on every document inside the scope assessed.
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.
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.
How a review is carried out
01
You choose what gets reviewed
Documents at Attest. The system and the complete file at Certify.
02
We match the expert to your device
You receive their name and relevant background before the work begins.
03
They read it against what applies
The requirements for your device and market. Section by section at Certify.
04
You receive the review record
Every finding tied to the material it came from.
What the record contains
The expert who read it, and the date
The scope of the review
Every document version read
The rubric version applied
Any earlier Venitara involvement
Running underneath all four steps
The two records
What each record covers
Every document a named expert reviews carries an attestation, and certification is issued once, covering the quality system and the complete file.
Venitara Attestation
Reference
VA-2026-0114, issued 14 March 2026
Reviewed
Clinical evaluation report, version 2.1
Against
MDR 2017/745, Annex XIV
By
A. Reviewer, Senior Regulatory Expert
Rubric
Venitara rubric v4.2
Findings
Corrections completed
Actions remaining open
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.
Venitara Certificate
Reference
VC-2026-0031, issued 28 June 2026
Company
Redacted GmbH
Scope assessed
Quality management system and complete technical file, MDR 2017/745
By
A. Reviewer and B. Reviewer, Senior Regulatory Experts
Rubric
Venitara rubric v4.2
Record
The Certificate states the scope, the document versions, and the status. The file stays private.
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.
The review status stays visible
Every document shows whether an expert has read it.
On the face of every Explore document
Not reviewed by a regulatory expert. Not suitable for submission.
Classification rationale
What the review record separates
Material Venitara prepared
Drafted, awaiting review.
Documents Venitara attested
Read by a named expert, on a stated date.
Anything outside the agreed scope
Named, so nobody assumes it was covered.
This is what human-led and AI-accelerated means here. The software drafts and keeps the file consistent. Judgement comes from a named expert, and only on the documents you have paid to have reviewed. The record says which those were, so anyone reading the file later can see it too.
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.
Who carries what
Who is responsible for what.
Venitara
Records what it did, and what it did not review.
The review record names who performed it, when, which versions were read, and what fell within scope. The assurance level on each document reflects that record.
Your organisation
You are the manufacturer.
Legal responsibility for the device and its file is yours, and no supplier can take it from you. The decisions stay yours.
The Notified Body
Decides certification, clearance and approval.
Where third-party conformity assessment is required, a designated Notified Body performs it within its scope. Those decisions remain with them, or with the relevant regulator.
Scope and limits
Three things Venitara does not do.
Act as a designated Notified Body
Venitara prepares and reviews files. It does not perform conformity assessment.
Issue conformity certificates
Certification, clearance, approval and market-authorisation decisions stay with the Notified Body or regulator.
Submit on your behalf
You remain the manufacturer, and the submission is made in your name.
No consultancy, platform or expert can control the timing or outcome of a Notified Body decision.
Money back on approval returns the fee. It does not return the year you spent.
Common questions
Who is the named expert?+
Before the review begins, Venitara confirms who will perform it and why their experience fits the product and market. The completed review identifies that expert and the date of the work.
Can I mix levels across one file?+
Explore and Attest mix freely across one file, document by document. Certification covers the system and the complete file, and every document inside the scope assessed carries its own attestation.
What happens if the expert disagrees with our position?+
The finding is recorded as they made it. A review that only confirms what you already believed has told you nothing, and it will not hold when someone independent reads the same file.
Does an attestation or a certificate expire?+
Neither is a status. Each is dated, tied to the document versions read and the rubric in force at the time. Once the file moves past those versions, the record describes what was true then.
What is the difference between an attestation and the certificate?+
An attestation covers one document: who read it, on what date, against which rubric. Certification is wider. It assesses your quality management system and the regulatory operation as well as the file itself, and it is issued once.
How is this different from a consultant's opinion?+
The review survives the engagement. It names the reviewer and the scope, ties findings to document versions, and records the rubric applied.
Need an expert read before the file leaves your company?
Attest covers your documents a stage at a time, each one read by a named senior expert. If you want the system assessed as well, and the certificate at the end of it, that is Certification. If you are still working out where to begin, the free MedTech Compass takes about ten minutes.
Free · AI generated · 10 mins