Use case · Notified body submission
Submitting your technical file soon? Make sure it lands complete, consistent and compliant.
My Audit Corner reviews your entire technical file the way the notified body will: against the MDR or IVDR and every standard that applies to your device. It flags what is missing, what contradicts itself and what is not compliant, then helps you draft the additions, ready to insert into the file.
Plug and play: MAC connects to your documents where they are. Nothing to migrate, nothing to configure.
What MAC changes on a submission
1 to 2
fewer rounds of questions with the notified body
-40%
less time spent on the technical file
+80%
more certainty of submitting a complete, consistent and compliant file
15 min
to check a 10,000-page file
Why technical files come back
An incomplete or inconsistent file is not rejected outright: it comes back with questions. And every question sends you to the back of the queue.
Each round trip costs months
The file comes back to you, you answer, and it goes back into the notified body's queue. Meanwhile the device is not on the market and the team stays tied up.
60% of rejection reasons: completeness and consistency
A general requirement pointing to missing evidence, a risk analysis that no longer matches the device version, a clinical evaluation that does not cover every claimed indication. Rarely a gross error, almost always a gap or a contradiction.
Nobody can cross-check everything by hand
The file is assessed against the MDR or IVDR, but also against every standard applicable to the device. The people who wrote it know what they meant: inconsistencies are invisible from the inside.
Preparing the file, without and with My Audit Corner
| Step | Without the tool | With My Audit Corner |
|---|---|---|
| Completeness | A checklist filled in by hand, document by document | The whole file is scanned: missing documents, signatures and mandatory data are flagged, 10,000 pages in 15 minutes |
| Consistency | Cross-reviews, when there is time left | The thread is followed across GSPRs, risk management, clinical evaluation, labelling and IFU; every contradiction is flagged |
| Compliance | The regulation on one side, the standards on the other | Every requirement of the MDR or IVDR and of the applicable standards is assessed, with a score backed by exact quotes from your documents |
| Draft what is missing | A blank page for every addition | The MAC assistant drafts from your documents and cites its sources: text you can use directly in the file |
| Prioritise | Everything feels urgent three weeks before submission | A prioritised action plan, with suggested content for each fix |
| Re-check | One last rushed review | The file is re-assessed after every fix, right up to submission day |
Completeness
Without the tool
A checklist filled in by hand, document by document
With My Audit Corner
The whole file is scanned: missing documents, signatures and mandatory data are flagged, 10,000 pages in 15 minutes
Consistency
Without the tool
Cross-reviews, when there is time left
With My Audit Corner
The thread is followed across GSPRs, risk management, clinical evaluation, labelling and IFU; every contradiction is flagged
Compliance
Without the tool
The regulation on one side, the standards on the other
With My Audit Corner
Every requirement of the MDR or IVDR and of the applicable standards is assessed, with a score backed by exact quotes from your documents
Draft what is missing
Without the tool
A blank page for every addition
With My Audit Corner
The MAC assistant drafts from your documents and cites its sources: text you can use directly in the file
Prioritise
Without the tool
Everything feels urgent three weeks before submission
With My Audit Corner
A prioritised action plan, with suggested content for each fix
Re-check
Without the tool
One last rushed review
With My Audit Corner
The file is re-assessed after every fix, right up to submission day
The file remains yours: your teams review, adjust and approve. MAC removes the checking work and the blank page, not the regulatory judgement.
Not the right time?
We know these weeks are intense. That is exactly what MAC is built for.
Before a submission, nobody has time to roll out a new tool. Good news: there is nothing to roll out. MAC is plug and play. You connect your document base, the analysis starts, and every benefit is there from the first assessment, not at the end of a project.
- Connected in a few hours to SharePoint, Google Drive, OneDrive, TraceX
- No migration, no change to your processes
- A first full assessment of the file as soon as it is connected
- With the Launch Pack, our team handles the setup: yours stays on the file
Two ways to move forward
With the tool, by your teams
Your teams connect the file, MAC assesses it, flags the gaps and helps with drafting. After CE marking, the same tool keeps the file up to date.
With our experts, fixed fee
Our experts carry out a critical review of your file before submission, with MAC as the engine, or build the file with you.
Frequently asked questions
No, it is actually the best time. MAC assesses what already exists and tells you what is missing, requirement by requirement. The earlier the assessment, the more time you have to fix things before submission.
Against the MDR (2017/745) or the IVDR (2017/746), including the general safety and performance requirements, and against every standard applicable to your device. That is what the notified body will check.
Yes. The MAC assistant drafts from your documentation and the regulation, citing its sources: justification of a requirement, completion of a section, alignment between two documents. The text can be used directly in the file; your team reviews and approves it.
A few hours. You connect your document base and MAC starts analysing. With the Launch Pack, our team handles everything and yours stays focused on the submission.
No. My Audit Corner connects to your existing environment (SharePoint, Google Drive, OneDrive, TraceX) and reads your documents where they are.
Never. Your documents are hosted in the European Union and are never used to train any model, neither for you nor for anyone else.
Your submission is coming up. Put every chance on your side.
30 minutes with our team: you connect your technical file and MAC produces its first analyses. You see right away what would stop the notified body.