RegStar

Lexim RegStar™ is designed to streamline the regulatory submission process for medical devices by providing comprehensive support for PreStar, nIVD, and IVD submissions. It offers templates tailored for these specific submission types, ensuring that all necessary fields are automatically populated based on user-provided data.

The platform enhances document management and organization by automating the organization of supporting documentation, implementing version control, and tagging metadata. This makes it easier for users to locate and manage their documents efficiently.

RegStar™ conducts automated compliance checks to ensure that submissions meet the requirements of FDA eSTAR or the EU’s CE mark. This feature helps in maintaining submission completeness and regulatory compliance.

Additionally, the system generates all necessary files for submission automatically, reducing the manual workload involved in preparing regulatory documents. It integrates with relevant regulatory databases to automatically populate data, minimizing the need for manual data entry.

Before finalizing submissions, users can perform a pre-submission review to verify the accuracy and completeness of their eSTAR submissions. This ensures that all information is correct and ready for submission.

• PreStar, nIVD, and IVD templates
• Automated template population
• Document management with version control
• Automated compliance checks
• Submission file generation
• Integration with regulatory databases
• Pre-submission review capabilities