ISO 13485 certification focuses on the requirements to establish and maintain a quality management system for companies that design and manufacture medical devices and equipment. Companies that have received ISO 13485 certification guarantee the safety of professionals and patients in clinics, hospitals and other medical facilities. ISO 13485 certification is a specific requirement for manufacturers of medical equipment. Ensures that the medical device company has established and maintained an effective quality system to develop, produce, test, inspect, verify, use, service, and repair its products.
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