Your AI assistant that secures your CE marking and your QMS.
MAC audits your Technical Dossiers (MDR & IVDR) and your ISO 13485 quality system continuously. Before certification, it detects gaps and prepares you for Notified Bodies. After, it maintains your compliance over time.
What you experience every day.
Manual auditing
Your RA/QA teams spend weeks manually reviewing hundreds of documents before each audit. A single oversight can cost you your certificate.
Hidden inconsistency
Your technical dossiers are dense, scattered, and no one has a comprehensive view of their coherence. One inconsistency between your GSPR, your risks, and your clinical evidence, and it's rejected.
False sense of completion
You've obtained your CE marking. But maintaining compliance costs as much as initial certification — and any regulatory change puts everything into question.
A strategic advantage, regardless of your situation.
MD / IVD Manufacturers
Transform your quality compliance maintenance into a peaceful routine. Secure your CE marking and drastically reduce your costs.
Medtech Start-ups
Build your QMS and technical dossier from scratch. Secure your Time-to-Market and reassure your investors without burning through your budget.
MDR / IVDR Transition
Does MDR/IVDR transition feel like a maze? Every document impacts another, and you don't know where to start. Get a clear roadmap in 24 hours.
Turnover & Onboarding RAQA
Secure the continuity of your compliance in the face of turnover. Make every new RA/QA resource operational from day one.
Consulting Firms & Consultants
Digitalize your advisory practice. Pre-audit your clients' dossiers in record time and build loyalty through continuous support.
Trusted by
Backed by
It's a fairly innovative solution. The demo was very interesting; I really like this kind of tools.
— Quality & Regulatory Affairs Manager, MD Manufacturer
Your MAC assistant's key capabilities.
Real-time ISO 13485 Gap Analysis
Ask for a real-time ISO 13485 gap analysis. It evaluates your compliance continuously, generates an overall score, and prepares you for Notified Body requirements.
CE marking technical dossier
Comprehensive evaluation of your CE marking technical dossier. The AI verifies the overall coherence of your information according to MDR / IVDR regulations before each submission.
Strategic anticipation & AI Chat
From uncertainty to strategic anticipation. Let MAC monitor regulatory developments: intimately knowing your QMS and Technical Dossiers, it generates a personalized and instant Gap Analysis to assess the direct impact of a new regulation on your products. Or simply ask it any question via the interactive chat.
3 sections impactées identifiées :
See your assistant in action on an internal audit.
Your new assistant's integration? 100% Plug & Play.
Forget months of transition to a new quality tool. A good assistant adapts to your methods, not the other way around. MAC connects to your current work environment. No data migration, no painful change management: plug in, analyze, correct.
Instant Connection
Your documents are scattered across SharePoint, Google Drive, or TraceX? Link them in 2 clicks. Don't change anything in your architecture.
Universal Analysis
Word, Excel, PDF, or even scanned documents... Your assistant reads, understands, and analyzes all your formats effortlessly.
Always Up-to-Date
Modify a document in your database, MAC automatically updates your compliance level.
Innovation in service of absolute security.
Your clinical data, your patents, and your technical dossiers remain your exclusive property. The MAC assistant analyzes your compliance in a strictly isolated environment. "No Training" policy guaranteed: our AI never trains on your intellectual property. Committed to ISO 27001 certification, we make our Pentest attestations available to you.
Trained by Medtech experts, powered by AI.
Behind your MAC assistant, there's more than just algorithms. It's been trained on years of regulatory affairs expertise. We've coded Notified Body requirements at the heart of its artificial intelligence to guarantee complete mastery of medical device and IVD regulations.
Transparent pricing for an expert always available.
Internalize the expertise of a premium auditor.
Choose your assistant's scope of action and confidently control the cost of your CE certification.
See our detailed pricing15,000 AI credits offered on your first server connection.
Frequently Asked Questions
My Audit Corner (MAC) is an AI assistant specialized in medical device compliance. It continuously audits your quality management system (QMS) against ISO 13485 and your technical files against the MDR (2017/745) and IVDR (2017/746) regulations. In practice, it detects gaps, document inconsistencies, and non-conformities before a Notified Body does.
No. MAC does not replace your quality manager, your RA/QA consultant, or your Notified Body. It acts as a permanent pre-auditor that works 24/7 so your teams can focus on strategy rather than document verification. The analyses generated are informational — the final decision always remains human.
Never. My Audit Corner enforces a strict "No Training Data" policy. Your documents feed an isolated, ephemeral model for the duration of the analysis, and are then immediately erased from the AI's memory. Your technical files, patents, and clinical data are never used to train the model — not for you, not for anyone else.
A few hours. MAC works in Plug & Play mode: you connect your document repository (SharePoint, Google Drive, OneDrive, or TraceX), and the assistant starts analyzing right away. No data migration, no change management, no weeks of training. Your team is operational from day one.
MAC reads and analyzes all common formats: PDF, Word, Excel, PowerPoint, and even scanned documents thanks to built-in OCR. Whether it's quality procedures, clinical evaluation reports, GSPR traceability matrices, or instructions for use (IFU), the assistant understands the structure and content of your regulatory documents.
Exclusively in the European Union, on Google Cloud Platform's secure servers. No external calls are made from the solution. All your exchanges are encrypted end-to-end. My Audit Corner is GDPR-compliant and pursuing ISO 27001 certification. Our penetration test reports are available upon request.
Yes. The assistant covers both medical devices (MDR 2017/745) and in vitro diagnostic medical devices (IVDR 2017/746). The audit modules — Smart QMS and Technical File — are designed to adapt to the regulatory specifics of each category.
Absolutely. We offer a personalized 30-minute onboarding with our team. You connect your document repository, and MAC generates its first analyses immediately. You see concrete results on your own data before making your decision.