Ask Us Anything: Human Factors for In Vitro Diagnostics (IVDs)

Overview

Our second thought leadership webinar featured an interactive Q&A session with our IVD human factors experts addressing key challenges in diagnostic device development. The session highlighted ClariMed's expertise in navigating the complex landscape of in vitro diagnostic regulations and practical implementation of human factors engineering for diagnostic devices.

Key Topics Covered

• CLIA waiver requirements and human factors evidence needed for at-home diagnostic devices

• FDA's new URRA guidance implementation and critical task analysis for IVDs

• Best practices for validation testing across diverse user populations and use environments

• OTC transition strategies and regulatory considerations when moving diagnostics direct-to-consumer

• Strategies for integrating human factors engineering throughout diagnostic device development lifecycle

• Home-use versus professional-use design considerations and their regulatory implications

• Current trends in diagnostic device usability and their impact on development processes