IVDrift regulate (AI)
Regina
Generate compliant documentation with our AI-powered tool, which compiles, verifies, and organizes data from diverse sources into comprehensive reports, streamlining collaboration and ensuring regulatory accuracy.
Creates the Performance Verification and Validation documentation, including the performance evaluation plan and the analytical and clinical performance reports
Creates the whole Technical Documentation from device description to Labels and Instructions for Use, through Benefit Risk Analysis and General Safety and Performance Requirements.
Creates the Performance Verification and Validation documentation, including the performance evaluation plan and the analytical and clinical performance reports
Creates the whole Technical Documentation from device description to Labels and Instructions for Use, through Benefit Risk Analysis and General Safety and Performance Requirements.
Regina Validates
Compilation for Analytical Performance Reports
Human Expertise Meets AI for Regulatory Excellence
Our tool efficiently compiles all relevant information from internal studies—such as linearity, limits, and reproducibility—regardless of the source, whether it’s a Word document, PDF, or Excel file with statistical analyses. It organizes this data into the correct format for generating analytical performance reports, ensuring nothing is overlooked. Additionally, the tool issues warnings for any missing information, guiding users to complete their submissions accurately and on time.
Human Expertise Meets AI for Regulatory Excellence
Our tool combines the backbone of deep regulatory knowledge with cutting-edge AI to deliver highly compliant solutions. By blending artificial and human intelligence, it structures your documentation based on proven regulatory frameworks. This synergy ensures your regulatory documents are crafted meeting the required standards and helping you navigate submissions with confidence.
Unmatched AI-Powered Solutions
Streamline Collaboration for Faster, Smarter Decisions
Our tool leverages multiple state-of-the-art AI models, including LLMs, SMLs, and proprietary algorithms, tailored to the task at hand. This ensures a unique product that delivers the best solutions for every regulatory challenge.
Streamline Collaboration for Faster, Smarter Decisions
Our tool is designed to simplify team collaboration, allowing multiple stakeholders to work together. With real-time editing, shared access, and customizable permissions, your team can review, comment, and refine documents keeping everyone on the same page. Whether you’re working with internal teams or external consultants, our platform ensures everyone stays aligned, reducing delays and accelerating your path to submission.
Regina Documents
Smart Assistant for Regulatory Documentation
Automated Compliance and Real-Time Alerts
Our AI-powered tool guides you through the regulatory documentation process with interactive tasks. Complex requirements are broken down into clear, manageable actions, ensuring accuracy and ease.
Automated Compliance and Real-Time Alerts
Stay confidently compliant with real-time alerts for new regulatory requirements. Our software keeps you informed of updates and provides reminders to maintain adherence without added effort.
Efficient Document Automation for IVD Certification
Complete Data Control with Easy Export Options
Designed to streamline certification, our software automates tedious documentation tasks, allowing you to focus on what’s important. By taking over routine work, the tool enhances efficiency and reduces the time required for regulatory submissions.
Complete Data Control with Easy Export Options
Our platform ensures complete ownership of your data, with the freedom to export all documentation and information whenever needed.