It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
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