Role of ISO 13485 in the Health Sector
The health sector depends largely on the most modern medical devices. Therefore, any compromise on the quality and safety of medical devices is simply impossible. A medical device could be an instrument or a machine, an implant or an in vitro reagent used in medical institutions for the diagnosis, prevention, and treatment of any medical disease or condition. ISO 13485 is an internationally accepted ISO standard that establishes the requirements for quality management systems by ISO 13485 Consultant that are specific to the medical device industry. This includes organizations that design and develop, manufacture and are providers of medical device installation and medical device consultant , as well as the manufacturers of their members or materials. Organizations in the medical device industry need to adhere to strict quality practices throughout the product cycle of the medical device. The main objective of ISO 13485 is to enable the requirements of the quality managem