evasmith1207 posted an update 1 year, 1 month ago
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 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.
https://www.iascertification.com/all-about-iso-13485/