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

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2025-11-10 10:52:28 - Μετάφραση

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

Organizations involved in the design, production, installation, or servicing of medical devices must comply with ISO 13485:2016, the international standard that defines the requirements for a quality management system (QMS) specific to the medical device industry. One of the essential components of implementing this standard is clearly identifying the applicability and exclusions of its...

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