Join date: Jul 12, 2021


ISO 13485 is a standalone quality management system standard for medical devices. The standard requires an organization to implement in one or more stages of the life cycle of a medical device so that it fulfills the Medical Device regulatory Compliances. The standard specifies the requirements of medical devices that help to be free from contaminants, sterilized, and maintain cleanliness in their entire life-cycle. ISO 13485 Certification in Germany


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