MedDeviceGuideMedDeviceGuide
Topic

Point-of-Care Testing

1 article

Point-of-Care Testing

Point-of-Care Testing (POCT): Regulatory Requirements, CLIA Waivers, and Market Trends

Comprehensive guide to point-of-care testing regulation — CLIA waiver requirements, FDA review pathways for POCT devices, EU IVDR classification, quality management, and the rapidly growing near-patient testing market.

›