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what is the Purpose of ISO 13485 Certification?

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Companies that have received ISO 13485 certification protect the safety of professionals and patients in clinics, hospitals, and other medical facilities. ISO 13485 certification focuses on the requirements for establishing and maintaining a quality management system for companies that design and manufacture medical devices and equipment. It is needed by the US Food and Drug Administration for medical device manufacturers who need ISO 13485 Certification67 before shipping their goods to the US.