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TAI #13: Risk Decisions Live in the Tension Between Data and Judgment
We often describe decisions as “risk-based,” yet much of what guides them is invisible. QMSR challenges leaders to become conscious of how judgment…
Feb 9
2
2
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
A deep dive into the newly released draft ISO/DIS 18969 standard on clinical evaluation, what it clarifies, and how it adds to current best practices.
Feb 6
2
27:50
TAI #12: When Emerging Safety Signals Fail to Escalate
Post-market surveillance often looks for stability, but emerging signals rarely arrive as clear trends. When escalation depends on certainty, early…
Feb 2
2
4
January 2026
LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
As FDA’s Quality Management System Regulation (QMSR) takes effect, software-driven medical device companies must rethink how agility and control can…
Jan 30
1
27:53
TAI #11: Safety Signals We Miss While Waiting for a Trend
Many safety issues begin as isolated events that never cross formal thresholds for action. When decisions wait for patterns to emerge, opportunities for…
Jan 26
LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
Why organizations struggle to connect Risk Management and Design Controls, and how collaboration, awareness, and continuous improvement make the…
Jan 23
3
1
26:11
TAI #10: Looking at Safety Through a Foggy Post-Market Lens
Post-market surveillance is designed to look for rising risk, but safety depends on whether risk remains acceptable in the context of benefit, and…
Jan 19
6
LTR 139: Steve Silverman on FDA Readiness for QMSR
As the QMSR compliance deadline approaches, former FDA compliance leader Steve Silverman offers an insider perspective on whether FDA itself is truly…
Jan 16
4
32:12
TAI #9: When Absence of Harm is Not Proof of Safety
Clean audits and green dashboards create a sense of reassurance. But the absence of harm does not necessarily mean safety is sustained. Understanding…
Jan 12
4
2
LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
As QMSR deadline approaches, Michelle Lott offers a candid assessment of industry readiness and explains why "hoping for more time" is not a useful…
Jan 9
4
1
29:42
TAI #8: One Question Every Risk Leader Should Ask in 2026
For years, leaders have measured success only by audit outcomes. But in 2026, the real challenge is building confidence that risk management is…
Jan 5
1
December 2025
Happy Holidays!
Wishing you a fun-filled Holiday Season and a Happy New Year!
Dec 22, 2025
•
Naveen Agarwal, Ph.D.
4
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