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Insight

Podcast Episode—QMSR Is in Effect: What IVD Manufacturers Still Need to Do

May 08, 2026

Insight

Designing a CLIA Waiver Comparison Study for a Near-Patient Molecular Diagnostic: Where Programs Run Into Trouble (Part 2 of 2)

April 15, 2026

Insight

PODCAST—Specimen Strategy Is Development Strategy: Why “We’ll Source It Later” Fails

April 03, 2026

Insight

CLIA-Waived POC vs. CLIA-Waived OTC: The Intended Use Decision and What It Commits You To (Part 1 of 2)

April 02, 2026

Insight

Semi-Quantitative Lateral Flow Assays: The Smart Middle Ground Driving the Next Wave of Diagnostic Innovation

March 25, 2026

Insight

QMSR Is in Effect: What IVD Manufacturers Still Need to Do (Even If You Follow ISO 13485)

March 18, 2026

Insight

PODCAST: Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio

March 18, 2026

Insight

PODCAST: Point-of-Care in 2025: Lateral Flow Grew Up. Where Will the Technology Go Next?

February 19, 2026

Insight

PODCAST: The DCN Dx Model: Integration, Scale, and What Comes Next with DCN Dx CEO Charlie Mamrak

February 06, 2026

Insight

PODCAST: Risk Management in IVD Development: A Regulatory Perspective

February 06, 2026

Insight

Point‑of‑Care in 2025: Lateral Flow Grew Up. Where the Technology Will Go Next

February 05, 2026

Insight

IVD Clinical Research Organization Evaluation & Comparison Rubric

January 29, 2026

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