The platform
Your quality system, your products, your company. Compliant, every day.
MAC connects to your documentation, assesses it continuously and tells you what to do. Your teams keep the decisions, MAC does the groundwork.
Example · Nordvale MedicalThree areas, one tool
Everything you need to keep compliant, in one place.
Each area covers what you own and what your notified body comes to check. Every feature is included in every plan.
Your quality system
An ISO 13485 QMS assessed continuously, ready for the surveillance audit.
- Continuous assessment, requirement by requirement
- Assisted internal audit
- Responses to audit nonconformities
- Several sites in a single view
Your products
MDR and IVDR technical files that are complete, consistent, and kept up to date after CE marking.
- Pre-submission check
- GSPR, risk and clinical consistency
- Impact of a product change
- PMS and PMCF commitments tracked
Your company
Reliable answers for all your teams, and a clear view for management.
- The MAC assistant, for every team
- Regulatory watch and standard impact
- A score per product for management
- A summary every week
How MAC works
Five moves, across every area.
Assess
Every requirement assessed, with a grade backed by exact quotes from your documents. Inconsistencies between documents are flagged.
Fix
Every gap becomes a concrete action, with the content to insert. Tasks are deduplicated and tracked until they are closed.
Steer
Scores per product, clear priorities and an assistant that answers with its sources. Management and the quality team see the same picture.
Monitor
Regulations, standards, product changes, post-market commitments: MAC tells you what moves and what it changes for you.
Connect
SharePoint, Google Drive, OneDrive, TraceX, Odoo, Confluence, Jira. Your documents stay where they are, no migration.
What they noticed
The system scans the entire standard, completely and far more often, where an internal audit only samples.
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.
A huge time saver: gaps are detected very, very quickly.
Your 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.
Your questions, answered.
Do we have to choose between the three areas?
No. The three areas are part of the same product, and every feature is included in every plan. Start with what worries you most: the rest is already there.
Does MAC replace our eQMS or document management system?
No. MAC connects to your existing tools and reads your documents where they are. There is nothing to migrate: MAC adds to your organisation, it does not replace it.
Is MAC a chatbot?
No. The assistant is only one of the ways to work with MAC. Most of the work happens without anyone asking: continuous assessments, action plans, alerts when a document, a standard or a product changes.
How do we qualify MAC in our quality system?
We provide a software validation file (ISO 13485, GAMP5) to qualify MAC as a tool of your QMS.
How long does it take to get started?
A few hours. You connect your document base and MAC starts analysing. With the Launch Pack, our team handles everything and yours has nothing to do.
See MAC at work on your own documents.
30 minutes with our team: you connect your documentation and MAC produces its first analyses.