ISO 13485 certification assures that medical device manufacturers satisfy stringent quality and safety standards. Professionals and patients in clinics, hospitals, and other medical facilities are protected by companies that have acquired ISO 13485. The requirements for creating and maintaining a quality management system for enterprises that design and produce medical devices and equipment are covered by ISO 13485. The US Food and Drug Administration requires ISO 13485 certification for medical device makers before shipping their products to the US.
ISO 13485 certification assures that medical device manufacturers satisfy stringent quality and safety standards. Professionals and patients in clinics, hospitals, and other medical facilities are protected by companies that have acquired ISO 13485. The requirements for creating and maintaining a quality management system for enterprises that design and produce medical devices and equipment are covered by ISO 13485. The US Food and Drug Administration requires ISO 13485 certification for medical device makers before shipping their products to the US.