Medical Device Quality System

Since its release in 1996, the ISO 13485 Medical Device Quality Management System Standard has been widely implemented and applied worldwide.
ISO13485 is a management standard applicable to regulatory environments; The name clearly indicates that it is 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 MDR (Medical Device Regulation) in the European Union, and the Medical Device Regulatory 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.