USA FDA PART211
ISO 13485:2003 is a management standard applicable to the regulatory environment: it is clearly defined as the quality management system requirements of the regulations. In the international arena, medical equipment is not only a general listed product operating in a commercial environment, but also subject to national and regional laws and regulations, such as the US FDA, the European Union MDD (European Medical Device Directive) and the Chinese medical device regulations. Therefore, the standard must be legally regulated by the regulatory environment and must take full account of the risks of medical device products and require risk management throughout the implementation of the medical device product. Therefore, in addition to special requirements, it can be said that ISO13485 is actually ISO9001 under the medical device regulatory environment. The United States, Canada and Europe usually use ISO 9001, EN 46001 or ISO 13485 as the requirements for quality assurance systems, and the establishment of medical device quality assurance systems is based on these standards.
UL is the abbreviation of Underwriter Laboratories Inc. UL Security Labs is the most authoritative laboratory in the United States and the world's largest private security testing and identification organization. It is an independent, profitable professional organization that tests public safety. It uses scientific testing methods to determine the hazards or hazards to life and property of various materials, equipment, products, equipment, buildings, etc.; to determine, prepare and promulgate appropriate standards, and to help reduce and prevent life. The property may lose information and conduct fact-finding. UL certification is a non-mandatory certification in the United States, mainly used for the detection and certification of product safety performance. The scope of certification does not include the EMC (electromagnetic compatibility) characteristics of the product. In short, it is primarily engaged in product safety certification and commercial safety certification, with the ultimate goal of obtaining fairly safe products for the market and helping to protect personal health and property. Regarding product safety certification as an effective means of eliminating technical barriers to international trade, UL is also playing an active role in promoting the development of international trade
The US Food and Drug Administration (FDA) is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulator, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices and radioactive products produced or imported in the United States. It was one of the first federal agencies to protect consumers as their primary function. Food, medicine, cosmetics and medical devices approved by the FDA are safe for humans. In nearly 100 countries, such as the United States, only commercial, clinical applications can be manufactured through FDA-approved materials, equipment, and technology