Explore FDA's QMSR and cybersecurity mandates for medical devices, including SPDF, SBOMs, and legacy medical device ...
Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...
Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
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 ...
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 ...
Dublin, June 27, 2024 (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 ...
The U.S. FDA’s Quality Management System Regulation (QMSR) is not technically in force until Feb. 2, 2026, but a new draft guidance from the agency’s device center seems to indicate that there is a ...
(MENAFN- GlobeNewsWire - Nasdaq) Explore the FDA's QMSR, key elements of QSIT cGMP inspections, and changes to medical device regulations. This seminar covers 21 CFR 820, CAPA, P&PC, risk management ...
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