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 ...
Recently, China's National Medical Products Administration (“NMPA”) released a new version of the Inspection Points for Clinical Trials of Medical Devices. This new rule replaces two previous versions ...
On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began ...
DUBLIN--(BUSINESS WIRE)--The "Inspection and Audit Readiness Training for Medical Device Manufacturers" training has been added to ResearchAndMarkets.com's offering. Recent US FDA inspections indicate ...
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 ...
Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).
Quality control is often still a manual process, particularly in medical device manufacturing. Vision inspection technology can help automate inspection, but manufacturers still face challenges.
At the forefront of medical innovations, medical device manufacturers have undergone a remarkable transformation in recent years, driven by technological advancements and heightened demands for ...
Opinion: Medical device companies can create a competitive advantage by leveraging data to strengthen compliance programs and ...
WASHINGTON, March 13 (Reuters) - The Trump administration is proposing to lift some limits on the use of ethylene oxide, a ...
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