Let's Talk Risk!
Naveen Agarwal, Ph.D.Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
| Platform |  | Pricing | Freemium | Publishes | Daily |
|---|---|---|---|---|---|
| Issues | 535 | Founded | 3 years ago | Last Issue | 3 days ago |
| Active | |||||
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naveenagarwalphd.substack.comLatest Issues
QMSR QuickTake #31: When Culture Becomes a Management Commitment Issue
In responding to Comment #27 in the preamble of the QMSR1, FDA stated that a culture of quality meets regulatory requirements through a set of behaviors, attitudes, activities and processes.
FDA’s response suggests that a culture of quali...
TAI #31: Who Is Really Making the Risk Decision?
Dear colleagues:
We often talk about risk-based decisions as if the main challenge is technical: gather the evidence, understand the tradeoff, and make the call.
But in matrix organizations, another problem often sits underneath the decis...
LTR 159: The Evolving Regulatory Landscape for AI in MedTech
Summary
“Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop”
Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices, quality sys...
QMSR QuickTake #30: Culture of Quality Is Not a Slogan
In responding to Comment #27 in the preamble of the QMSR1, FDA stated that it expects medical device manufacturers, led by individuals with executive responsibilities, to embrace a culture of quality.
That phrase can sound broad, even soft...
TAI #30: Is Your PMS Managing Risk or Just Documenting Complaints?
Dear colleagues:
In MedTech, many organizations believe they have an active Post-Market Surveillance (PMS) process. But in practice, what they mostly have is vigilance.
They gather complaints, review events, and decide whether something m...
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MedTech risk management advisor, educator, and creator of Let’s Talk Risk! Sharing ideas on risk, quality, leadership, and decision-making under uncertainty.
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