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ISO 13485 Medical Devices Quality Management System

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ISO 13485 Medical Devices Quality Management System

ISO 13485 Quality Management System for Medical Devices ISO 13485, developed for the Quality Management System (QMS) of medical devices, includes specific requirements for medical devices. Basic Training This training helps participants thoroughly understand the basic requirements, definitions, and explanations of ISO 13485:2016. By completing this training, participants will grasp the concept of regulatory QMS in medical manufacturing or service organizations and its relationship with other standards. Implementation Training After completing this training, participants will have the knowledge and experience necessary to implement the QMS in their organization in accordance with ISO 13485:2016 requirements for medical devices. The training examines standard, sector, and product requirements, providing a process-based perspective for manufacturing and service-providing businesses. Internal Auditor Training Through this training, participants will learn the principles and practices of conducting quality management system process audits according to ISO 19011, as required by ISO 13485:2016.

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