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 ...
DONGGUAN, GUANGDONG, CHINA, January 13, 2026 /EINPresswire.com/ -- As healthcare moves toward proactive and at-home ...
The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...
Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR ...
This course covers changes from ISO 13485:2003 to the ISO 13485:2016 standard and their impact on a company’s Quality Management System (QMS). Topics include the Annex SL framework, methods for ...
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 ...
Introduces early stage audit readiness solutions to streamline ISO 13485 certification for medical device and IVD companies inline with MDR, IVDR and FDA QMSR CHARLOTTE, NC, UNITED STATES, April 29, ...
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