# Dan Simpson
ထိပ်တန်း Podcast တခုကိုဖြစ်စဉ်များ
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Top podcast episodes featuring dan simpson.
Predetermined Change Control Plans (PCCPs) for AI-Enabled IVDs
A DCN Dx Expert Insights conversation with Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, and Emily Friedland, VP of Clinical Research at DCN Dx.
FDA’s Predetermined Change Control Plan (PCCP) mechanism is designed to let manufacturers pre-specify certain post-clearance or post-approv…
Fear Is a Clue, Not a Crutch with Dan Simpson of Taziki's Mediterranean Cafe
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Zack Oates sits down with Dan Simpson, CEO of Taziki’s Mediterranean Cafe, for a wide ranging conversation on leadership, fear, and building a truly people centered restaurant brand. Dan shares his unconventional path from founding a tech company to leading a growing hospitality br…
Mortgage 101
-A deep dive into the mortgage and real estate market with leading industry veteran: Dan Simpson
QMSR Is in Effect: What IVD Manufacturers Still Need to Do
In this episode, Emily Friedland, VP of Clinical Research at DCN Dx, talks with two guests who come at QMSR from different directions: the regulatory strategy side and the quality systems implementation side.
Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, covers the regulatory framing…
Wellness or Medical Device? FDA's 2026 Wellness Guidance and the WHOOP Warning Letter
In July 2025, FDA told WHOOP that its Blood Pressure Insights feature was an unauthorized medical device. WHOOP disputed FDA’s position and kept selling it. In January 2026, while the dispute was still open, FDA reissued its general wellness guidance. FDA closed the warning letter in June after WHO…
After the Court Vacated FDA’s LDT Rule: What IVD Developers Still Need to Get Right
After a federal court vacated FDA’s final rule for laboratory-developed tests (LDTs) in 2025, did the LDT pathway fully reopen? Not exactly.
In Season 3, Episode 15 of Expert Insights, host Emily Friedland, VP of Clinical Research at DCN Dx, speaks with Jesse Young, Ph.D., Medical Director of Clin…
What Breakthrough Designation Does and Doesn't Do for an IVD
What does FDA Breakthrough Device designation mean for an in vitro diagnostic (IVD)? Learn what it takes to qualify, what evidence supports a request, and how designation can shape development and clinical study planning.
In this episode of Expert Insights, Dan Simpson, RAC, Director of Regulatory…
What's in your nightmare / The airplane seat that might actually work / The world needs more Dan Simpsons
Researchers have a new model for treating chronic nightmares in kids — and the key insight is that it's not the nightmare itself that keeps them coming back, it's the child's response to waking up. Also: a double-level airplane seat concept called the Chaise Longue is back with its "final statement…
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If I have seen further than others, it is by listening to podcasts and standing upon the shoulders of
giants.
‐ Isaac "Llamacorn" Newton
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