Medtech quality and regulatory affairs
Compliant products. A relieved team. Audits without surprises.
MAC takes care of the tasks that keep your products and your company compliant.
What changes
Weeks of work, given back to your teams.
My Audit Corner is the AI harness for medtech quality and regulatory teams: a platform of autonomous agents, orchestrated for each business task according to your products, your standards and your documentation.
Explore the AI architectureWhat they noticed
What our users have to say.
The nonconformities raised during the audit had all been identified by the tool beforehand. No surprises on the day.
The system scans the entire standard, completely and far more often, where an internal audit only samples.
A tool that clearly makes us more efficient and productive, especially for maintaining the quality system once certified.
After certification
After certification, the real work begins.
CE marking is not a finish line. Keeping a product compliant on the market is so demanding that the notified body comes back every year. MAC takes on this day-to-day work with your team.
The groundwork, handled by MAC
Your team
And time freed up to
SharePoint
Google Drive
Confluence
JiraWhat is worrying you today?
You are: MD / IVD manufacturer · Medtech start-up · Medtech subcontractor · MDR / IVDR transition
Checking that marketing material matches the instructions for use took us ages. The software compares everything automatically and forgets nothing.
Management and quality team
One picture for management and the quality team.
A score per product, red, amber and green priorities, and explanations in plain language rather than regulatory jargon. Everyone knows where the company stands, without translation meetings.
Example · Nordvale MedicalGroundwork no longer ties up your teams for weeks on end.
Files go out complete, without avoidable back-and-forth.
The same figures and the same priorities for everyone.
Gaps are seen before the notified body sees them, not during the audit.
For our teams to have a clear mind for R&D and creating value for patients, rather than spending their time on legacy regulatory work.
How it works
You connect. MAC takes care of the rest, with you.
SharePoint, Google Drive, OneDrive, TraceX, Odoo, Confluence, Jira. No migration: your documents stay where they are.
Word, Excel, PDF, even scanned. It checks your documents against each other, against ISO 13485, MDR and IVDR requirements, and against external sources: EUDAMED, audit reports.
A summary in a few lines, the 10 priority topics, an action plan per topic, and the source of each action.
When a document changes, MAC reassesses everything it affects.
Thank you for being so responsive, and what pleases me most is that I had nothing to do!
Who is behind MAC
Built by people from the field.
My Audit Corner was born in a medtech. Sébastien Risler co-founded one in 2020, sold it to Biosynex in 2022, then led the group's regulatory affairs.
Lead investor
The points My Audit Corner raised are exactly the ones worth discussing. We no longer start from a blank page as in a classic audit.
I believe in it because I see it. It seems hard to believe, and yet it is there: an extremely powerful help.
A huge time saver: gaps are detected very, very quickly.
Two ways forward
With the platform, or with our experts.
Services
MAC ServicesGap analysis, internal audit, technical file review, outsourced PRRC: our experts deliver the service, with the platform as their engine.
Discover our servicesYour documents stay yours.
Hosted in the European Union, isolated environment, No Training Data policy: the AI never trains on your files. ISO 27001 process under way, pentest certificates available.
Frequently asked questions
Your questions, answered.
We are already certified. What is MAC for?
That is where it helps most. After certification, documents evolve, standards change, marketing asks for changes and PMS and PMCF commitments pile up. MAC monitors all of this continuously and flags what drifts before the surveillance audit.
Why not use Copilot or ChatGPT?
A general-purpose assistant answers a question about a few documents. MAC connects to your entire document base, thousands of files, structures it against ISO 13485, MDR and IVDR requirements, and directly produces assessments, action plans and ready-to-use answers, at the quality level you aim for. There is nothing to build on top.
Does MAC replace our quality team?
No. MAC does the groundwork: finding gaps, planning how to close them, preparing responses. Your team keeps the decisions and gains time for strategy, management and improvement. Analyses are for information; the decision remains human.
How long does it take to get started?
A few hours. You connect your document base (SharePoint, Google Drive, OneDrive, TraceX, Odoo, Confluence, Jira) and MAC starts analysing. No migration, no change management.
Where is our data hosted, and is it used to train the AI?
Exclusively in the European Union, on Google Cloud Platform, with encrypted exchanges. Your documents are never used to train a model, for you or for anyone else.
Which documents can MAC analyse?
PDF, Word, Excel, PowerPoint and scanned documents: procedures, clinical evaluation reports, GSPR matrices, risk analyses, instructions for use.
Does MAC cover medical devices and IVDs?
Yes: medical devices (MDR 2017/745) and in vitro diagnostic devices (IVDR 2017/746), as well as the ISO 13485 QMS.
Can we try before committing?
Yes. In 30 minutes with our team, you connect your document base and MAC produces its first analyses on your own documents.
Take back control of your compliance.
30 minutes with our team, and you see MAC working on your own documents.
15,000 AI credits offered as soon as you first connect your server.