A Quality Management System (QMS) is a formal system of business processes, procedures, and standards coordinating and directing an organization’s efforts to continually meet customer and Regulatory requirements and maintain its effectiveness and efficiency.
The Quality Management System (QMS) for medical devices is a formalized system of procedures covering all aspects of the medical device life cycle such as design, development, testing, manufacturing, supplier management, risk management, clinical data, documentation control, Corrective And Preventive Action (CAPA), change management, storage, distribution, and labeling that ensure the devices are safe and effective for the end user.
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