Venitara Certification Preparation Sprint
Submission Ready
EU technical file completion and conformity-assessment readiness
A senior regulatory expert reads your technical file against the criteria a Notified Body assessor applies, and writes down what needs to change.
Where this sits
01Pathway
Ready
02Market
Ready
03Company
Ready
04Evidence
Ready
05Submission
ReadyYou are here
06Revenue
Ready
Your file, growing. Each stage begins with the work already in it.
Available at any stage
When to use Submission Ready
A submission date is set, or a Notified Body application is going in. The technical file exists. Nobody inside the company can say whether it survives being read by someone who does this for a living.
Without this review, the first person to tell you the technical file is wrong is your Notified Body assessor, and that answer arrives months after you submitted. A correction at that point means resubmitting and waiting again for a review slot.
What you receive
The Submission-Ready Technical File
The complete technical file, assembled and cross-checked, with a readiness finding on every section. Where you select expert review, each document a named expert reads carries its own Attestation, stating the reviewer, the date, the version read, and the rubric applied.
What it contains
A readiness finding on every section of the technical file
An Attestation on each document you select for review
Corrections completed and actions still open, shown separately
A current view of where your conformity assessment stands
What the review covers
Each item is read against the requirement it has to satisfy. The regulatory basis is stated so you can check the reading yourself.
| Document | Read against |
|---|---|
| Technical documentation | MDR 2017/745, Annexes II and III |
| General safety and performance requirements | MDR Annex I |
| Risk management file | ISO 14971 |
| Clinical evaluation report | MDR Annex XIV |
| Post-market surveillance plan | MDR Article 84 |
| Labelling and instructions for use | MDR Annex I, Chapter III |
| Declaration of conformity | MDR Annex IV |
| UDI assignment and EUDAMED registration | MDR Articles 27 and 29 |
For an in vitro diagnostic, the same work runs against IVDR 2017/746, with performance evaluation in place of clinical evaluation.
Who does the review, and against what
The rubric was built by a regulatory professional who assesses technical files for a Notified Body. The criteria are the ones an assessor applies, in the order an assessor applies them.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects. The reading you get here is the reading you are about to receive anyway.
What you can do with the result
You find the gap before your assessor does, while closing it still costs a revision.
You also hold a dated record you can put in front of a board, an investor, or an acquirer without opening the technical file to them. The Certificate states the scope, the versions, and the status. It does not show the technical file.
An external reading settles arguments a team has been having internally, because the finding is written down and attributed to the person who made it.
The three levels for this product
Explore | Attest | Certify | |
|---|---|---|---|
| What you get | The technical file assembled from your own answers | Each selected document read by a named senior expert and attested | The system and the complete technical file independently 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 |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document | The Certification seal, on the certificate |
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.
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
Perform conformity assessment.
Venitara prepares and reviews regulatory files. Where third-party conformity assessment is required, a designated Notified Body performs it within its scope.
Submit on your behalf.
You remain the manufacturer, and the submission is made in your name.
Guarantee approval, or a date.
Certification, clearance, approval, and market-authorisation decisions stay with the Notified Body or the regulator, and so does their timing.
No consultancy, platform or expert can control the timing or outcome of a Notified Body decision.
Where this leads
Before
Evidence Ready.
If the link between the requirements and the evidence you hold is not yet mapped, that work comes first. Everything it produces carries forward into this one.
After
Revenue Ready.
A CE mark permits you to sell. Reimbursement decides whether anyone pays. That work can start before the certificate arrives.
Common questions
Who reads my technical file?+
A named senior regulatory expert, confirmed to you before the review begins, with their experience against your product and market. The completed review identifies that expert and the date of the work.
What if the technical file is not ready?+
You are told so, in writing, with the sections that fall short and what closes each one. A review that only confirms what you already believed has told you nothing.
Can you review a technical file we built elsewhere?+
Yes. The review identifies the reviewer, the date, the scope, and the document versions covered, whoever built the technical file.
Does the Attestation expire?+
It is not a status. It is dated and tied to the versions read and the rubric in force at the time. Once the technical file moves past those versions, the record describes what was true then.
Do we have to take the whole technical file at once?+
No. Attest applies document by document, so you can start with the sections carrying the most regulatory consequence. Certification covers the system and the complete technical file.
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