Smart QMS: The eQMS that audits your QMS continuously.
Entrust the monitoring of your QMS to your AI assistant. From internal quality auditing to CAPA generation, master your ISO 13485/MDR compliance through data, with zero migration effort.
Continuous Evaluation (Procedures & Records)
MAC continuously scans your QMS against ISO 13485 and MDR/IVDR regulations. The assistant audits your records in real-time (often filled by other departments less familiar with regulatory rigor) to ensure no errors have crept in.
Action Plan Generation (The key asset for your teams)
The evaluation doesn't stop at findings. This is your assistant's main strength: as soon as a gap is detected, the AI instantly generates detailed, prioritized actions with content to insert into your documents. Your teams are guided, stay operational, and know exactly what to correct.
Scoring & Trends (Management's steering tool)
At a glance, directors get an objective, justifiable compliance score (A to F) to know exactly where the company stands in its compliance progress. Automatic notifications on trends (upward or downward) ensure strategic alignment across all departments and bring absolute peace of mind.
Automated Internal Audits
Planning, expert grid generation (up to 800 questions), and automated reports for your ISO 13485 internal audit. Auditing becomes a moment of reflection around company improvement rather than an administrative burden.
Cross-Reference Consistency Check
A modified procedure that contradicts an old validation protocol? A reference to a document that no longer exists? The human eye will miss it, but AI won't. MAC maps your entire system to guarantee absolute document consistency.
Document validation is an ultra time-consuming task. Humans always risk missing a detail. Your software, by automatically comparing information, will miss nothing.
Multi-QMS Management (Multi-site & Subsidiaries)
Managing multiple entities? MAC consolidates the compliance of all your quality management systems (QMS) within a single interface. No more information silos - you maintain total control over your entire ecosystem.
Ready to see MAC in action?
Connect your document repository and let your AI assistant audit your compliance today.
Roadmap — Vote for the next features
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QMS Change Management
Automatic evaluation of the regulatory impact of any procedure modification on your overall compliance.
Supplier Management
Automated analysis of supplier certificates and continuous monitoring of their quality level.
External Audit Response
Generation of pre-filled reports and centralization of evidence to instantly respond to external auditors.
MDSAP Audits
Extension of MAC's evaluation capabilities to MDSAP-specific requirements for international market access.