Since its release in 1996, the ISO13485 medical device quality management system standard has been widely implemented and applied around the world.
ISO13485 is a management standard applicable in a regulatory environment; from the name, it is clearly a quality management system requirement for regulations.
Internationally, medical devices are not only general marketed commodities operating in a commercial environment, but also subject to the supervision and management of national and regional laws and regulations, such as the FDA in the United States, the MDR(European Union Medical Device Regulation) in the European Union, and the Medical Device Directive in China. Device Regulations.Therefore, the standard must be constrained by law and operate in a regulatory environment. At the same time, the risk of medical device products must be fully considered, and risk management must be carried out in the entire process of medical device product realization. So in addition to special requirements, it can be said that ISO13485 is actually ISO9001 in the context of medical device regulations.
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