We’ve just updated our Page. Visit our Page to see the latest updates. Fast-track your lab-developed test (LDT) migration to in vitro diagnostic (IVD) test and approval with the LDTtoIVD AI Agent and AI Assistant. Implement IVDs in weeks instead of years. The LDTtoIVD IRIS Agent creates regulatory strategy, literature study, scientific study, performance study, analytical study, clinical study, stability study, shipping study, product validation, manufacturing validation, labeling, GSPR, STED, DOC, 510(k), PMA that meet relevant regulations and standards for: 1. Medical Device ISO 13485, FDA QSMR, MDSAP, and EU IVDR 2017/746 Regulations 2. LDT ISO 15189, CLIA, and CAP Assay Products Migration to US FDA IVD Compliance Requirements 3. LDT ISO 15189, CLIA, and CAP Assay Products Migration to EU IVDR Compliance Requirements AI Agent analyzes the information you provide and uses machine learning models trained on clinical laboratory data from various IVD discipline such as chemistry, genetic testing, hematology, immunology, microbiology, molecular diagnostics, pathology, toxicology, trace elements and more. The model leverages FDA, EU and ROW Regulations, ISO Standards and Guidance's, CLSI Standards, ANSI Standards and other relevant regulations.?
LDTtoIVD.AI
医疗和诊断实验室
Sunnyvale，CA 3 位关注者
Accelerate LDT to IVD approval with AI-powered IRIS: Regulatory, Clinical, and Quality Strategies for Global Compliance
关于我们
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.
- 网站
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https://www.ldttoivd.ai
LDTtoIVD.AI的外部链接
- 所属行业
- 医疗和诊断实验室
- 规模
- 2-10 人
- 总部
- Sunnyvale，CA
- 类型
- 私人持股
- 创立
- 2024
- 领域
- 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和Virology
地点
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主要
获取路线
US，CA，Sunnyvale，94087