LDTtoIVD.AI

Accelerate LDT to IVD approval with AI-powered IRIS: Regulatory, Clinical, and Quality Strategies for Global Compliance Get Started with IRIS AI Agent Submit your lab developed test, in vitro diagnostic or research use only test product information to our AI Agent Our AI Agent will do all the work and create the following: 1. Regulatory Strategy Governance - Documentation for Regulatory Strategy Plan, Pre-Sub Submissions, Q-Submissions, Scientific Validity and Literature Review, Analytical and Clinical Study Plan, Cost, and Protocols. 2. Product Realization Governance - Documentation for Design controls documentation for Medical Device File and Design History File consisting of User Requirements, Product Requirements, Risk Management File, Design Verification, Design Validation, AI Verification and Validation, Clinical Study Reports, Stability, Product Labeling, Manufacturing Process Validation, and Device Master Record. 3. Regulatory Submission Governance - Documentation for 510(k), PMA, EU Summary of Technical Documentation (STED), General Safety and Performance Requirements (GSPR), and Declaration of Conformity 4. Product Post Market Surveillance Governance - Documentation for Post Market Surveillance Plan and Reports, Post Market Clinical Follow-up Plan and Reports, Periodic Safety Update Reports. 5. Product Intelligence Governance - Documentation for Regulatory Intelligence Report, Clinical Intelligence Report, and PMS Intelligence Report. 6. Quality Management System Governance - Documentation for Quality Manual, Quality System Procedure and Work Instructions based on ISO 13485, ISO 15189, ISO 14971, ISO 62304, MDSAP, CLIA, CAP, NYSDOH requirements. Training, Person Responsible for Regulatory Compliance Agreement, Notified Body Agreement, Authorized Representative Agreement, Importer Agreement, Distributor Agreement.