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 ...
Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ...
The FDA has notified the medical device manufacturing sector that ISO-13485(2016) will be recognized as a Quality Management System Consensus Standard. In February 2026, the FDA will move away from ...
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 ...
Industry representatives and members of the US Food and Drug Administration’s (FDA) Device Good Manufacturing Practice Advisory Committee (DGMPAC) embraced the agency’s proposal to align US quality ...
Company is among the first in China's drug-device combination products sector to obtain this certification, delivering superior solutions to global clients Zero non-conformities demonstrates company's ...
The U.S. FDA’s effort to marry its quality systems regulations with ISO 13485 has hardly gone off without a hitch, but Melissa Torres, director of international programs at the FDA’s device center, ...
The global ophthalmic industry is undergoing a significant transformation, driven by a growing demand for personalized vision correction and high-precision optical solutions. At the heart of this ...
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