HETAIDA full range of thermometer products have been certified by the FDA QSR820 quality system.
The FDA quality system specification QUALITY SYSTEM REGULATION-Chinese version (QSR820) describes the current requirements of the production management specification (CGMP) in this quality system specification. This specification requires that all medical device products be designed, manufactured, packaged, and labeled. , methods, facilities and controls used in storage, installation and service. These requirements are to ensure the safety and effectiveness of finished medical devices and to comply with the US Food, Drug, and Cosmetic Act. This specification sets out the basic requirements applicable to manufacturers of medical device products.