RegStar

Lexim RegStar™ is a powerful, affordable, and fast submission preparation software designed for medical device manufacturers seeking to streamline and accelerate the regulatory approval process. By automating key steps across the entire submission workflow — from template population and document organization to compliance checks and final file generation — RegStar™ helps teams reduce submission timelines, minimize errors, and gain a competitive edge in bringing devices to market.

RegStar™ is purpose-built to support submissions for FDA eSTAR and EU CE mark requirements, with dedicated template support for PreStar, nIVD, and IVD submission types, making it a versatile solution for a broad range of medical device regulatory needs.

Key Capabilities

• PreStar, nIVD, and IVD Support: Ready-to-use templates are available for PreStar, nIVD, and IVD submission types, covering a wide spectrum of medical device categories.
• Automated Template Population: The platform automatically fills in required fields within submission templates based on user-provided information and data, significantly reducing manual effort.
• Document Management and Organization: RegStar™ provides streamlined management of all supporting documentation, including automated organization, version control, and metadata tagging to make information easy to locate and manage.
• Compliance Checks: Automated compliance checks verify submission completeness and adherence to FDA eSTAR or EU CE mark requirements, helping teams catch issues before they cause delays.
• Automated Submission Generation: The platform generates all required submission-ready files, removing the burden of manual assembly and formatting.
• Integration with Regulatory Databases: RegStar™ connects with relevant regulatory databases to automatically populate data, minimizing manual data entry and reducing the risk of errors.
• Pre-Submission Review: Users can review eSTAR submissions for accuracy and completeness prior to finalization, ensuring confidence before official submission.

What Users Are Saying

• "Lexim helped my medical-device company gain a deep understanding of AI and its applications to Regulatory Affairs." — Tatyana G., Vice President of Regulatory Affairs

Lexim RegStar™ is part of Lexim AI's broader suite of regulatory solutions, which also includes RegIntel for medical device, pharmaceutical, and consulting firms, and Device Lens for medical device analytics. Together, these tools are designed to simplify compliance and accelerate approvals across the life sciences industry.