ISO 13485 Quality Management System Certification

Date:2019-10-15

ISO 13485 Quality Management System Certification
HETAIDA full range of thermometers have been awarded ISO 13485 certification
 
ISO13485 Chinese is called “Medical Device Quality Management System for Regulatory Requirements” Since medical devices are special products for life-saving, disease prevention and treatment, it is not enough to standardize only according to the general requirements of ISO9000. For this reason, ISO organization has issued ISO13485: The 1996 edition standards (YY/T0287 and YY/T0288) have set special requirements for the quality management system of medical device manufacturers, which has played a very good role in promoting the safety and effectiveness of medical devices.