ISO13485 is a quality management system standard for medical devices. Since its release in 1996, it has been widely implemented and utilized throughout the world. iso13485 is a management standard that applies to regulatory environments; it is clear from its name that it is a quality management system requirement used for regulatory purposes.
Medical devices in the international arena are not only general listed commodities operating in a commercial environment, but they are also subject to the supervision and management of national and regional laws and regulations, such as the U.S. FDA, the European Union's MDD (European Union Medical Devices Directive), and China's Medical Device Regulation.
Therefore, the standard must be bound by law and operate in a regulatory environment, and at the same time, it must give full consideration to the risks of medical device products and require risk management in the whole process of realizing medical device products. So in addition to the specialized requirements, it can be said that ISO 13485 is actually ISO 9001 in a medical device regulatory environment.
Standard changes:
ISO 13485:2012 is the standard used in the European Union, and the current international standard is still the ISO 13485:2003 version. The 2012 version of the upgrade compared to ISO 13485:2003 changes are as follows, ISO 13485:2012 in the preamble part of the standard to make appropriate adjustments.
The main changes are the terminology changes, as well as some details of the scope of application, in the appendix part of the larger changes made in the revision of the ANNEX ZA, ANNEX ZB and ANNEX ZC three catalogs, increased ISO 13485 and the relationship between the three medical device directives. The 2012 version of this update is worth looking forward to, the standard is still only implemented in the European Union, the domestic still use ISO 13485:2003.