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Join date: Mar 23, 2022

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ISO 13485 certification is for organizations that develop and manufacture medical devices and equipment, and focuses on the standards for creating and maintaining a quality management system. The safety of professionals and patients in clinics, hospitals and other medical institutions is guaranteed by companies that have achieved ISO 13485 certification. Medical device manufacturers must have ISO 13485 certification. It verifies that the medical device company has implemented and maintained an effective quality system for developing, manufacturing, testing, inspecting, verifying, using, maintaining and repairing its products.iso 13485 certificering