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 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 ...

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 ...

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 ...

On Feb. 2, 2024, FDA published its long-awaited amendment to its current good manufacturing practice requirements for medical devices. The new Quality Management System Regulation (QMSR) now ...

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 ...

For years, the medical device industry has been expecting the alignment of FDA’s 21 CFR Part 820 quality system regulation (QSR) with the international ISO 13485 standard. FDA issued a proposed rule ...

The U.S. FDA’s proposal to restructure the Quality System Regulation (QSR) with ISO 13485, the international quality system standard, is a major shift for affected industry, but there are strictly ...

WuXi Biologics, a leading global contract research, development and manufacturing organization, announced that it has successfully achieved ISO 13485:2016 Medical Device Quality Management System ...

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 ...

“Product revenue for the OneRF brain ablation system in the second quarter of fiscal 2026 grew 72% year-over-year to $2.4 million compared to $1.4 million in the second quarter of fiscal 2025,” said ...