Let's Talk Risk!
Naveen Agarwal, Ph.D., Jonathan KendlerWhere MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
| Platform |  | Pricing | Only free issues | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 551 | Founded | 3 years ago | Last Issue | 6 days ago |
| Active | |||||
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naveenagarwalphd.substack.comLatest Issues
QMSR QuickTake #36: Why Batch and Lot Still Matter
In responding to Comment #29 in the preamble of the QMSR1, FDA addressed several terminology questions, including correction, corrective action, preventive action, and the definition of batch or lot.
One detail is easy to miss: FDA intende...
TAI #36: When The Average Hides Uneven Benefit-Risk
Dear colleagues:
Business teams naturally favor broad intended-use and indication statements. A wider population expands patient access and commercial opportunity, and positive clinical-trial results may appear to support that breadth.
Bu...
LTR 162: Using HHE for Risk-Based Decisions
Summary
“When done well, HHE evolves from a procedural requirement into a strategic tool that reflects how your organization makes risk-based decisions.”
In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks...
QMSR QuickTake #35: CAPA Effectiveness Is Not a Closure Checkbox
In responding to Comment #29 in the preamble of the QMSR1, FDA reminded manufacturers that corrective and preventive actions must be verified or validated to ensure they are effective and do not adversely affect the finished device.
This i...
TAI #35: From Passive Surveillance to Active Evidence
Dear colleagues:
Many post-market surveillance systems are built to receive complaints, adverse events, service records, literature, and field reports. These inputs are essential, but they are largely reactive. They tell us what has alread...
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Authors
The writers behind this newsletter.
MedTech risk management advisor, educator, and creator of Let’s Talk Risk! Sharing ideas on risk, quality, leadership, and decision-making under uncertainty.
Jonathan is a human factors engineer and product designer specializing in medical devices. For 20+ years, he's helped teams improve device safety and usability while meeting international regulations. Currently Principal Consultant at Curiolis.
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