Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
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naveenagarwalphd.substack.comLatest Issues
QMSR QuickTake #45: An Accessory Is a Finished Device for Regulatory Purposes
In responding to Comment #34 in the preamble of the QMSR1, FDA addresses an important quesiton - does QMSR need a separate definition of “accessory”?
FDA concluded that it does not. For purposes of QMSR, FDA considers an accessory to be a...
TAI #45: How Supplier Controls Drift During the Lifecycle
Dear colleagues:
At product launch, manufacturers may have strong visibility into the supplier processes and characteristics that support device safety. Specifications are current, process validations are recent, safety-related characteris...
LTR 164: Susan Neadle on Combination Device Risk Management
Summary
“ISO 14971 and ICH Q9 are not competing frameworks. They are asking different questions about risk.”
In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Susan Neadle, Principal Consultant and...
QMSR QuickTake #44: A Device Can Be “Finished” Before It Is Final
In responding to Comment #33 in the preamble of the QMSR1, FDA addresses an important boundary question: when is something a component, and when has it become a finished device?
That distinction matters because QMSR generally applies direc...
TAI #44: The Supplier Risk Traceability Gap
Dear colleagues:
In a recent post, we looked at whether characteristics related to safety remain traceable to the hazards and harms they influence, and to the processes and suppliers responsible for controlling them.
The next gap often ap...
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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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