LumiDocs

LumiDocs is building AI-powered solutions to drastically reduce the compliance burden for medical device manufacturers. We’re working closely with early customers to tailor our platform to real-world needs. 📅 Book a meeting here → https://calendly.com/ms-lumi-docs/30min ✅ AI-Automated Audits (Available Now) - 🔍 Scan quality, technical, and clinical documents to detect thousands of potential gaps across standards like ISO 14971, ISO 13485, ISO 14155, and more - in just hours - 📄 Receive clear, actionable mitigation steps to help regulatory experts move faster and empower non-regulatory staff or founders to take control 🛠️ Automated Remediation (Coming Soon) - 📋 Browse a prioritized list of compliance gaps and choose which to address - 💬 Add context or instructions, then ask the LumiDocs Assistant to generate and return updated documents - 🔁 Gaps are resolved one by one through a structured pipeline. 📂 QMS Manager (In Development) - 💬 Chat with your AI compliance agent directly via Slack, Email, or your preferred channels - ⚙️ Build custom workflows to automate repetitive compliance tasks - ⏱️ Stay ahead of deadlines, track document changes, and monitor adherence to maintain continuous compliance