Ask MAC & Monitoring: Medical device regulation in real time.
Transform your inactive documents into an interactive expert. Query your QMS in natural language and let your assistant anticipate the impact of new standards on your products.
"Ask MAC" Chat - Your daily copilot, even during audits.
Why search for hours? During an R&D meeting or facing a demanding auditor, ask MAC: 'Where is the aging test evidence for batch X?'. The assistant reads all your databases (PDF, scans, Word) and instantly displays the sourced evidence. Your data stays with you. MAC never uses it for training.
Our regulatory department spends 50% of its time handling repetitive internal requests. Having a chatbot based on company data that automatically retrieves previously given answers is exactly what we need.
Enhanced Regulatory Monitoring
Tracking 200 standards is impossible for a human. MAC permanently monitors databases (including Eudamed), harmonized ISO standards, and MDCG guidelines. MAC informs you of regulatory changes that may impact your system.
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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Normative Gap Analysis
MAC will tell you exactly which line of your technical dossier needs updating following a new standard publication.
ePRRC
An exclusive dashboard for the PRRC. MAC centralizes regulatory data to enable compliance oversight and responsibility fulfillment.
eEU Representative
Secure centralization of regulatory information to ensure the European authorized representative fulfills legal obligations.
eImporter
A dedicated interface to simplify documentary compliance control of incoming devices and ensure traceability.
eDistributor
A lightweight solution to quickly verify compliance of distributed devices and maintain required regulatory registers.