ISO 13485

Introduction to ISO 13485 Medical Devices Editor
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes is the current version up to November 2017.
----The following is an introduction to the old version, which has been invalidated. Some content can still be referenced-----
The full name of ISO 13485:2003 standard is "Medical device quality management system requirements for regulation". This standard was developed 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 ISO9001 standards in the medical device industry.
Since its release in 1996, this standard has been widely implemented and applied worldwide. The new version of ISO13485 standard was officially released on July 3, 2003. Unlike the ISO 9001:2000 standard, ISO 13485:2003 is a management standard applicable to regulatory environments: it is explicitly named as a quality management system requirement for regulatory purposes. Medical devices are not only commonly listed products operating in commercial environments internationally, but also subject to supervision and management by national and regional laws and regulations, such as the FDA in the United States, the MDD (Medical Device Directive) in the European Union, and the Medical Device Supervision and Management Regulations in China. Therefore, this standard must be legally binding, operate in a regulatory environment, and fully consider the risks of medical device products, requiring risk management throughout the entire implementation process of medical device products. So, in addition to specific requirements, it can be said that ISO13485 is actually ISO9001 under the regulatory environment of medical devices.
The United States, Canada, and Europe generally require ISO 9001, EN 46001, or ISO 13485 as quality assurance systems, and the establishment of medical device quality assurance systems is based on these standards. Medical devices entering markets in different countries in North America, Europe, or Asia should comply with corresponding regulatory requirements.

Applicable objects of ISO 13485
Medical product manufacturers and service providers who comply with international, European, and domestic legal and regulatory requirements, as well as enterprises that wish to implement a documented management system in accordance with this standard.
Enterprises that develop, manufacture, and sell medical equipment and want to showcase their competitive and performance capabilities in international, European, and domestic markets. Suppliers and other service providers within the value-added chain must ensure that their products are consistent with customer requirements.