The "Navigating Regulatory Compliance Whilst Developing and Distributing Polymerase Chain Reaction (PCR)-Based IVD Tests Training Course (May 15, 2026)" has been added to ResearchAndMarkets.com's ...

In brief, LDTs are in vitro diagnostics (IVDs) that are intended for clinical use and are designed, manufactured, and used within laboratories that are certified under the Clinical Laboratory ...

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...

This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...

Reghelps SRC offers targeted services to support Indian IVD manufacturers facing challenges in complying with European In ...

Significant changes to EU digital health regulation lie ahead this year, Mason Hayes & Curran has highlighted. The business ...