ISO 13485 certification ensures that medical device manufacturers meet stringent quality and safety standards. Professionals and patients in clinics, hospitals and other medical facilities are protected by companies that have obtained ISO 13485 certification. Requirements for creating and maintaining a quality management system for businesses that design and manufacture the medical devices and devices covered by ISO 13485 certification. The US Food and Drug Administration requires ISO 13485 certification for medical device manufacturers. economy before shipping their products to the United States. chứng nháºn iso 13485
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