ISO 13485

An instrument, equipment, appliance, software, substance, or other thing intended for human use for the diagnosis, prevention, monitoring, treatment, or relief of disease is described as a “medical device" by ISO 13485. The ISO 13485 standard applies to the following medical devices:https://iasiso-asia.com/VN/blog/iso-13485/

ISO 13485 Certification | ISO 13485 in Vietnam - IAS Vietnam

ISO 13485 certification verifies that a medical device manufacturing company has implemented a quality management system to ensure the safety medical devices.