Medical Device Quality Management System (MDQMS), is a systematic procedure and process covering all the aspects of design, manufacture, and distribution. MDQMS is required for all medical device and the complexity will vary with varying risk class of medical device. Most of the regulatory authorities across the world require proper implementation and maintenance of the quality management system. For placing the medical devices in European market, the manufacturer is required to comply with the requirements of ISO 13485 and companies who want to sell their products in USA have to comply with the Quality System Regulation (21 CFR 820). Under the new European Regulation (EU MDR), it is now obligatory for even the manufacturers of low risk class devices to have a basic QMS in place.
ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Regulations. ISO 13485 certification is not mandatory CE marking medical device organization. ISO 13485 is harmonized to EN ISO 13485, which allows compliance of conformity to European device regulations..