ISO 13485 is a QMS standard that comes from the internationally recognized and accepted ISO 9000 quality management standard series. If you’re looking to establish a device’s effectiveness, then this ISO 13485 for Medical Devices might be the system for you.
The overall goal of the standard is to reduce the risk associated with medical devices and technologies. To accomplish this, ISO 13485:2016 outlines certain requirements that a company must meet.
