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Accelerate Your Device Approval: Master Device Submissions with Lexim RegStar™

Lexim’s RegStar™ preparation software offers a powerful, affordable, fast solution that transforms the way medical device manufacturers navigate the submission requirements. Our platform streamlines every step, from intelligent template population and document organization to automated document generation and compliance checks. With RegIntel, you can significantly reduce submission timelines and minimize errors. Get your devices to market faster and gain a competitive edge with RegIntel's submission automation.

Lexim RegStar™

Key Capabilities:


  • PreStar, nIVD, and IVD Support: Templates for PreStar, nIVD, and IVD available


  • Automated Template Population: Automatically fills in required fields within the template based on user-provided information and data


  • Document Management & Organization: Streamlined management of supporting documentation, including automated organization, version control, and metadata tagging, making it easier to find information


  • Compliance Checks: Conducts automated checks to ensure submission completeness and compliance with FDA eSTAR or EU’s CE mark requirements


  • Automated Submission Generation: Generates the required files ready for submission.


  • Integration with Regulatory Databases: Connects with relevant regulatory databases to automatically populate data, minimizing manual data entry


  • Pre-Submission Review: Allows users to review eSTAR submissions for accuracy and completeness before finalization


What Our Clients Say

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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."

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