After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
AI-enhanced vision systems automate medical device quality control, replacing manual inspection with flexible solutions.
On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...
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For many industries and applications, implementing inspection at the point of assembly improves quality of the supply chain while reducing the impact of downstream detection of defects. Eliminating ...
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