RegIntel

RegIntel™ for Medical Devices provides comprehensive global regulatory intelligence by offering instant access to regulations and guidances from over 80 countries, including major regions like the USA and EU, all consolidated in one platform.

With advanced AI-driven analysis, users can swiftly summarize complex regulations, identify key action items, create FAQs, and assess the impact of new requirements. This functionality significantly reduces manual workload and provides actionable insights promptly.

The platform includes a built-in standards search feature, enabling users to quickly locate and reference thousands of medical device standards necessary for ensuring safety and performance compliance.

Users can access extensive datasets, including device data, recalls, 510(k) submissions, PMAs, and records of adverse events, facilitating informed, data-backed decision-making at every stage of the product lifecycle.

Additionally, RegIntel™ assists in developing and comparing market entry strategies across different countries, aiding in strategic planning and execution.

Client Feedback

Tatyana G., Vice-president of Regulatory Affairs, noted that Lexim's platform significantly enhanced her company's understanding of AI applications in Regulatory Affairs.