Tiger Liu

## Abstract Navigating regulatory pathways is critical for IVD manufacturers entering global markets. This application note compares FDA 510(k), CE-IVD (EU IVDR), and NMPA (China) registration requirements for POCT devices, providing a practical framework for regulatory strategy planning. ## Introduction The global IVD market is highly regulated, with each major market requiring distinct approval pathways. … Read more

# RPA Integration in POCT After-Sales Technical Support Workflows ## Introduction After-sales technical support is a critical differentiator in the competitive POCT market. Customers expect rapid response times, accurate troubleshooting, and seamless service experiences. However, managing technical support across global customer bases with diverse devices and issues is operationally complex. Robotic Process Automation (RPA) can … Read more

# RPA Automation of POCT Product Registration Documentation for Global Markets ## Introduction Bringing POCT devices to global markets requires navigating complex regulatory landscapes across multiple jurisdictions. Each country has unique registration requirements, documentation standards, and submission processes. Manual preparation of regulatory dossiers is time-consuming, error-prone, and delays market entry. Robotic Process Automation (RPA) can … Read more

# RPA in POCT Clinical Trial Data Management: Ensuring Data Integrity and Compliance ## Introduction Clinical trials involving POCT devices generate vast amounts of data that must be managed with absolute precision. From patient enrollment to final data lock, clinical trial data management requires meticulous attention to regulatory requirements, data integrity, and audit trails. Robotic … Read more

# RPA-Driven Preventive Maintenance Scheduling for POCT Devices ## Introduction Preventive maintenance (PM) is critical for ensuring POCT device reliability and accuracy. However, managing maintenance schedules across hundreds of distributed POCT instruments is a logistical challenge. Robotic Process Automation (RPA) can revolutionize PM scheduling by automating tracking, notifications, work order generation, and compliance documentation. ## … Read more

# RPA in POCT Quality Control Data Analysis: Automating Levey-Jennings Charts ## Introduction Quality control (QC) is the backbone of reliable POCT results. Clinical laboratories and point-of-care facilities generate thousands of QC data points daily, requiring meticulous analysis to ensure assay performance remains within acceptable limits. Traditional manual QC data analysis is time-consuming and prone … Read more

# OEM/ODM Custom Assay Development Workflow for POCT ## Abstract Custom assay development requires structured collaboration between POCT manufacturers and reagent suppliers. This application note outlines the OEM/ODM development workflow for lateral flow immunoassays, molecular diagnostics, and TRF platforms, from biomarker selection to regulatory submission. ## Introduction IVD companies increasingly outsource assay development to specialized … Read more

# Lyophilized Reagent Technology for Room-Temperature POCT ## Abstract Lyophilization (freeze-drying) enables room-temperature storage of temperature-sensitive POCT reagents, eliminating cold chain requirements. This application note details lyophilization protocols for lateral flow strips, PCR reagents, and CRISPR-based diagnostics for POCT manufacturers. ## Introduction Cold chain logistics account for 30-40% of POCT reagent costs in developing markets. … Read more

# Accelerated Stability Testing Protocol for POCT Reagents ## Abstract Stability testing is critical for POCT reagent registration and quality assurance. This application note describes an accelerated stability testing protocol for lateral flow strips, immunoassay reagents, and molecular diagnostic consumables, enabling POCT manufacturers to predict shelf life efficiently. ## Introduction Regulatory requirements (FDA, CE-IVD, NMPA) … Read more

# Whole Blood Sample Processing for Lateral Flow Immunoassays ## Abstract Direct whole blood analysis on lateral flow strips presents significant challenges due to matrix effects, hemolysis, and non-specific binding. This application note outlines sample processing strategies for POCT manufacturers developing lateral flow immunoassays that accept untreated whole blood specimens. ## Introduction Whole blood is … Read more