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 ...

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 ...

For several years, FDA has bared its teeth in response to drug and medical device facilities’ unwillingness to share requested documents. The Agency has done so by citing the delays in Form FDA-483 ...

Food and Drug Administration has issued a warning letter to Philips after inspections at three of its medical device ...

Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...

A high-resolution X-ray visual inspection system was developed for noncontact, nondestructive inspection of products in the medical device and pharmaceutical packaging industries. Porosity and voids ...

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 ...