SuperIntelligence meets Regulatory Intelligence for Compliance with Clinical Precision
Navigating the complex world of medical device regulations is a significant challenge. RegIntel for Medical Devices, powered by Lexim Praxis, provides a comprehensive, one-stop solution to streamline regulatory processes, reduce time-to-market, and ensure compliance across global markets. This AI driven platform offers a centralized hub for accessing, analyzing, and managing the ever-evolving regulatory landscape, empowering regulatory affairs professionals to accelerate time to market, increase compliance, and reduce risk
RegIntel’s Business Impact
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80+ Global Agencies | 5,000+ Guidance Documents with Analyses | 1,600+ Standards Information | 100M+ Device Data Points |
RegIntel™ for Medical Devices
What RegIntel™ for Medical Devices Can Do for You
Global Regulatory Intelligence: Get instant access to regulations and guidances from 80+ countries, including the USA and EU—all in one place.
Advanced Analysis: Use AI to quickly summarize regulations, flag key action items, create FAQs, and understand the impact of new requirements—saving hours of manual work and delivering insights you can act on immediately.
Built-In Standards Search: Quickly find and reference thousands of medical device standards to meet safety and performance expectations.
Dataset Access: Explore device data, recalls, 510(k)s, PMAs, and adverse events. Make confident, data-backed decisions at every stage.
Market Entry Strategies: Generate and compare go-to-market strategies across countries.
See the difference for yourself:
What Our Clients Say
Tatyana G., Vice-president of Regulatory Affairs
"Lexim helped my medical-device company gain a deep understanding of AI and its applications to Regulatory Affairs."