The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...
Dublin, June 28, 2024 (GLOBE NEWSWIRE) -- The "The US FDA QMSR Transition - 21 CFR 820 and ISO 13485" training has been added to ResearchAndMarkets.com's offering. The US FDA, after years of ...
The medical device sector must meet stringent regulatory requirements plus convince potential customers that they make reliable, safe products. Having a strong commitment to quality can help customers ...
SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (BIOR) (Nasdaq: BIOR), the biotech company reimagining therapeutic delivery, today announced it has been awarded ISO 13485:2016 ...
Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system. ISO 13485, the ISO standard for medical device quality ...
This course is based on the 2016 version of the ISO 13485 Standard, providing skills necessary to perform internal process audits in the medical device industry. It features a detailed review of the ...
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