#361: Speaking the Language of IVD

Global Medical Device Podcast · 19 Apr 2024 · 44m · Episode 361

What this episode covers

Christie Hughes, a principal consultant and IVD expert at Qserve Group, explains the distinct regulatory, design, and risk management requirements for in vitro diagnostics (IVDs) compared to general medical devices. She details how IVDs are classified by complexity, the critical importance of user needs for diverse operators ranging from lab technicians to laypeople, and the specific hazards of false positives and negatives. Hughes also highlights the current industry upheaval caused by the FDA's proposed rule on Laboratory Developed Tests (LDTs) and the ongoing transition to the European IVDR, noting the significant compliance burden for labs and manufacturers alike.

Most relevant to

early-stage companies

Topics

Mentioned

Companies: Qserve Group
Also: FDA, IVDR, CDRH, ISO 13485, ISO 14971, CLIA

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#361: Speaking the Language of IVD

What this episode covers

Most relevant to

Topics

Mentioned

Related episodes from other shows

154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell

244 - 5 Critical Quality Differences Between Drugs and Devices

055 - "Critical Tasks and Knowledge Tasks" with Alexandra Benbadis

099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson

258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin