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ISO 13485 Certification is used by organizations involved in medical devices and related services. It keeps professionals and customers safe in clinics, hospitals, and other medical settings. ISO 13485 is the internationally recognized quality management benchmark for medical device manufacturers. The aim of ISO 13485 is to ensure that medical devices and services consistently meet customer expectations and relevant regulatory requirements. These organisations are indulged in one or more life-cycle stages such as design, storage and distribution, production, development, installation or servicing of a medical device and design and development or provision of any associated activities/ services.

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