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ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices. ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.
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ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in I...
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