ISO 13485 applies to medical device industries and manufacturers (those involved in the design, production, installation, and servicing of medical devices and any related services). In this case, a medical device is defined as a product (ranging from larger machines to in vitro reagents to individual tools) that is intended for use in the prevention, diagnosis, and treatment of diseases or other medical conditions. It’s one of the most comprehensive standards for medical device manufacturers to use in order to meet customer and applicable QMS regulatory requirements. Quality management system ISO 13485 is an international and very commonly used QMS regulatory standard for medical devices.
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