The FDA’s regulations and expectations for medical devices are designed to ensure that benefits outweigh the risks. In three months, the U.S.
Dublin, Nov. 26, 2024 (GLOBE NEWSWIRE) -- The "Inspection and Audit Readiness Training for Medical Device Manufacturers-Live, Online Training" training has been added to ResearchAndMarkets.com's ...
FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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 ...
Medical Device Network on MSN
FDA hits Philips with warning over manufacturing site deficiencies
In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...
Dublin, July 10, 2025 (GLOBE NEWSWIRE) -- The "The FDA QMSR and the Key Elements of QSIT cGMP Inspection and Audits for Medical Device Manufacturers" training has been added to ...
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 ...
The U.S. Food and Drug Administration has flagged three of Philips' medical device facilities after inspections found they ...
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