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Beschreibung ISO 13485 is a quality management system standard for medical devices & equipment. The standard requires an organization to implement in one or more stages of the life cycle of a medical device that helps it fulfill the Medical Device Regulatory Compliances. The standard specifies the requirements of medical devices to be free from contaminants, sterilized, and maintain cleanliness in their entire life-cycle. Letzte Aktivitäten Verlinkungen |
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