Podcast Episode—QMSR Is in Effect: What IVD Manufacturers Still Need to Do
What changes for IVD developers and manufacturers now that the FDA Quality Management System Regulation is in force, and where the gap work tends to land.
Insight
Designing a CLIA Waiver Comparison Study for a Near-Patient Molecular Diagnostic: Where Programs Run Into Trouble (Part 2 of 2)
Study design decisions that determine whether your CLIA waiver data will stand up to FDA review.
Insight
PODCAST—Specimen Strategy Is Development Strategy: Why “We’ll Source It Later” Fails
Jim Boushell, Senior Vice President of Biospecimens at DCN Dx, joins Mitzi Rettinger to talk about what experienced IVD teams define early in their specimen plans and what goes wrong when they don’t.
Insight
CLIA-Waived POC vs. CLIA-Waived OTC: The Intended Use Decision and What It Commits You To (Part 1 of 2)
Developers of near-patient molecular diagnostic tests encounter the term “CLIA-waived” early in their regulatory planning and often treat it as a single destination.
Insight
Semi-Quantitative Lateral Flow Assays: The Smart Middle Ground Driving the Next Wave of Diagnostic Innovation
By Pat Vaughan, Ph.D., Chief Operating Officer, DCN Dx
Insight
QMSR Is in Effect: What IVD Manufacturers Still Need to Do (Even If You Follow ISO 13485)
Educational content only.
Insight
PODCAST: Automation Beyond the Strip: Building Repeatable Rapid Test Production with KinBio
Scaling rapid test manufacturing from benchtop assays to high-throughput, controlled production.
Insight
PODCAST: Point-of-Care in 2025: Lateral Flow Grew Up. Where Will the Technology Go Next?
Lateral flow diagnostics are no longer just assays, they’re integrated systems.
Insight
PODCAST: The DCN Dx Model: Integration, Scale, and What Comes Next with DCN Dx CEO Charlie Mamrak
How an integrated services model reduces handoffs across development, clinical work, regulatory planning, manufacturing, and biospecimens, and how DCN decides what to build next.
