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.
Company Details
- Founded
- -
- Address
- Sunnyvale, Ca 94087, Us
- Industry
- Medical And Diagnostic Laboratories
- NAICS
-
Medical and Diagnostic LaboratoriesMedical LaboratoriesDiagnostic Imaging Centers
- Website
- https://www.ldttoivd.ai
- Keywords
- Medical Devices, Software as Medical Devices, IVD, LDT, ISO 13485, ISO 15189, CLIA, CAP, AI/ML, FDA QSR 820, MDSAP, ISO 22989 AI System Life Cycle Process, ISO 42001 AI Management System, ISO 23053, and ISO 24029, AI Systems Using Machine Learning Models, ISO 24027, and ISO 25024 AI System Data Quality Integrity, ISO 24368 AI Human Centered Interaction Design, ISO 24368 AI System Complying to Ethical and Societal Concerns, ISO 27001, ISO 27701 AI Information Security, Cybersecurity, and Privacy Protection, Chemistry, Immunology, Genetics, Molecular Diagnostics, Virology.
- HQ
- Sunnyvale, CA
Ldttoivd.ai Questions
Ldttoivd.Ai's website is https://www.ldttoivd.ai
Ldttoivd.Ai's LinkedIn profile is https://www.linkedin.com/company/ldttoivd
Ldttoivd.Ai's industry is
Medical and Diagnostic Laboratories
Ldttoivd.Ai's top competitors are
Doyle Trade Llc,
I-Import Wholesale & Distribution,
Caring Hands Medical Lab Services,
2sd Toxicology Services,
Tgs Delivery,
Lincoln Community Health Central Lab,
Llc Doyle Trade,
New World Int'l Holdings Corp.,
Touchoverseas Business Solutions,
Rasti Professional Services Inc..
Ldttoivd.Ai's categories are Medical and Diagnostic Laboratories
Ldttoivd.Ai's founding year is 2024
