Where MedTech professionals gain clarity and confidence to navigate complex risk, quality, and leadership challenges.
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QMSR QuickTake #42: DHF Expectations Under the Design and Development File
In responding to Comment #31 in the preamble of the QMSR1, FDA also addressed the future of the Design History File (DHF).
Under the former QS Regulation, the DHF provided the evidence that a device was developed in accordance with the app...
TAI #42: How Much Confidence Is Enough?
Dear colleagues:
In a recent TAI post, we looked at where uncertainty enters a risk estimate: the pathway to harm, probability, severity, risk control effectiveness, and the strength of the supporting evidence.
Recognizing uncertainty is...
Deep Dive: What FDA’s QMSR Warning Letters Are Revealing
If you’re trying to manage risk in isolated silos, your quality management system is already obsolete.
What happens when a supplier changes a device label without triggering design controls? When operators quietly rework nonconforming prod...
QMSR QuickTake #41: DHR Expectations Under the Batch Record Framework
In responding to Comment #31 in the preamble of the QMSR1, FDA addressed the future of familiar QS Regulation record terms, including Device History Record (DHR). Under the former QS Regulation, the DHR had a clear role. The Device Master R...
TAI #41: Uncertainty in Our Risk Estimates
Dear colleagues:
We are accustomed to estimating risk, assigning a category in a risk matrix, and documenting whether residual risk is acceptable. Once that rating appears in the risk file, it can begin to look more certain than the eviden...
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