On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
Pat Shrader, Medtronic’s vice president for global regulatory affairs, testified (PDF) at a House subcommittee hearing this week, urging Congress to “improve” the inspection of medical device ...
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 ...
The medical technology sector has been a leader in innovation for a long time, and now the regulations are changing accordingly. As a result of digital transformation and worldwide ...
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 ...
Just 27% of 230 medical device makers surveyed expect to be in full compliance with the European Union’s Medical Device Regulation (MDR), which goes into effect in May next year, a study has found.
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US FDA Inspection on Rise: Indian Pharma and Medical Devices Manufacturers Strengthen GMP Compliance
City, India, December 23, 2024: In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device manufacturers are enhancing their Good ...
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