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ISO 13485 certification is a defined compliance method that allows medical device manufacturers to improve their product quality. ISO 13485 certified companies have indeed demonstrated their commitment to quality and patient safety. Companies that have achieved ISO 13485 certification help protect the safety of professionals and patients in clinics, hospitals and other medical facilities. ISO 13485 certification is required for medical equipment manufacturers. It certifies that the medical device company has established and maintained a quality system for the creation, manufacture, testing, testing, use, maintenance and repair of its products.

certificazione iso 13485

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