Medical devices
Cooperating for the safety, quality and performance of medical devices
Introduction to the Global Harmonisation Task Force (GHTF) for Medical Devices, an informal platform for regulatory authorities and representatives of industry from Europe, the United States of America, which goal is to provide a forum for national regulatory authorities and industry representatives in the field of medical devices to promote international convergence in regulatory requirements and practices.
Health care and medical devices
ISO 13485 certification helps Beckman Coulter meet regulatory deadline for medical devices. Beckman Coulter, Inc.,implemented ISO 13485 to meet a new medical device regulation requiring registration to the standard.
Quality management systems for the medical device industry
ISO has just published a standard to facilitate implementation of quality management systems based on ISO 9001:2000 by the medical device industry.
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