In this free webinar, see how audit readiness can be strengthened as the FDA transitions from QSIT to QMSR. Attendees will learn about the implications of the shift from inspection-based QSIT to a ...
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 ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...
On Monday, February 2, a new final rule from FDA changing QMS requirements for medical devices went into effect. Manufacturers have had over two years to comply with the new rule, which is now full ...
AI-enhanced vision systems automate medical device quality control, replacing manual inspection with flexible solutions.
DUBLIN, Jan. 29, 2021 /PRNewswire/ -- The "Inspection Machines Market by Product (Vision Inspection, Checkweigher, Metal Detector, Software), Type (Manual, Automatic ...
In this free webinar, gain insight into how product safety compliance applies to connected medical devices and the testing pathways that support market access. Attendees will learn about the essential ...
When was your last FDA inspection? You may believe that the likelihood of an FDA inspection happening to your company is low. However, medical device companies registered with FDA with class II and ...
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