Where in the Organization Should the Applicability and Exclusions...

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2025-10-29 09:31:39 -

Where in the Organization Should the Applicability and Exclusions to ISO 13485 Requirements Be Stated?

ISO 13485 is the globally recognized quality management system (QMS) standard specifically designed for organizations involved in the design, production, installation, and servicing of medical devices. It ensures that medical devices consistently meet customer and regulatory requirements. One of the crucial aspects of ISO 13485 implementation is defining the applicability and exclusions of its...

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