شناسه: ISO 13485:2016
عنوان: Medical devices — Quality management systems — Requirements for regulatory purposes
قیمت: ۵۳۰۰ تومان (۱۰ درصد تخفیف اعضاء ویژه)
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).