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ISO 13485

ISO 13485

ISO 13485 helps you to meet the requirements that apply to your Quality Management System (QMS). Medical device manufacturers can use ISO 13485 to support the effectiveness of their processes.

ISO 13485 is the internationally recognized standard for quality management in the medical device industry. It ensures an organization’s commitment to continuous improvement in terms of the design, safety and quality of medical devices, and it meets all industry requirements.

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