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 #39: DMR, DHF, and DHR Expectations Under a New Framework
In responding to Comment #31 in the preamble of the QMSR1, FDA addressed a major terminology change: the terms Device Master Record (DMR), Design History File (DHF), and Device History Record (DMR) are not retained in QMSR.
For many FDA-fo...
TAI #39: When Current Controls Are Not Enough
Dear colleagues:
In recent TAI posts, we have challenged two assumptions in our risk files.
First, risk control effectiveness is more than showing that individual controls were implemented and verified. Second, FMEA may identify failure m...
Deep Dive: Designing Safety Into Autonomous Robotic Devices
The vulnerability of the modern clinical lab is quite literally concentrated at the point of the needle.
Clinical laboratories have automated almost everything after the blood reaches the tube. Yet one of the most common invasive procedu...
QMSR QuickTake #38: "Documented" Does Not Mean Paper-Only
In responding to Comment #30 in the preamble of the QMSR1, FDA addressed the term “establish.” Under the former QS Regulation, “establish” was defined as define, document, and implement. Commenters asked FDA to retain that definition in QMS...
TAI #38: Are We Asking Too Much of FMEA?
Dear colleagues:
In a recent TAI post, we argued that risk control effectiveness depends on understanding what controls are expected to interrupt the failure trajectory that leads to a hazardous situation and harm.
This week, the questio...
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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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