ISO13485 is called "medical device quality management system" in Chinese. Since medical devices are special products that save lives, heal the wounded, prevent and cure diseases, it is not enough to standardize only the general requirements of the ISO9000 standard. /T0287 and YY/T0288), put forward special requirements for the quality management system of medical device manufacturers, which has played a good role in promoting the quality of medical devices to be safe and effective.IntroductionThe full name of the ISO13485:2003 standard is "Medical device-Quality management system-requirements for regulatory". The standard is formulated by the SCA/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee and is an independent standard based on ISO9001:2000. The standard specifies the quality management system requirements for relevant organizations, but it is not a guide for the implementation of the ISO9001 standard in the medical device industry.Since the standard was released in 1996, it has been widely implemented and applied all over the world. The new ISO13485 standard was officially released on July 3, 2003. Different from the ISO9001:2000 standard, ISO13485:2003 is a management standard applicable to 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 MDD (European Union Medical Device Directive) in the European Union, and the Medical Device Directive in China. Regulations on the Supervision and Administration of Devices. 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.The United States, Canada and Europe generally take ISO 9001, EN 46001 or ISO 13485 as the requirements of the quality assurance system, and the establishment of the medical device quality assurance system is based on these standards. To enter the market of different countries in North America, Europe or Asia, medical devices should comply with the corresponding regulatory requirements.standard changeISO 13485:2012 is the standard used by the European Union. The current international standard is still ISO 13485:2003. The upgrade of the 2012 version has the following changes compared to ISO 13485:2003. ISO 13485:2012 is in the preface of the standard. Appropriate adjustments have been made, mainly in terms of wording, and some revisions to the details of...

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