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 ...
THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...
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 ...
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 CHARLOTTE, NC, UNITED STATES, April 29, ...
Dublin, Jan. 27, 2026 (GLOBE NEWSWIRE) -- The "An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices Training Course (May 21, 2026)" training has been added to ...
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 ...
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 ...
BUFFALO GROVE, ILLINOIS / ACCESS Newswire / February 4, 2026 / PPC Flex, a leader in high-performance sterile and ...
PLEASANTON, Calif.--(BUSINESS WIRE)--Boyd Corporation, a global leader in sealing, protection and thermal management solutions, announced their facility in Chonburi, Thailand has achieved ...
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