On the 2nd of October, Avaintec received the ISO 13485 certification for medical devices and quality management systems. It means that Avaintec’s quality system officially complies with the requirements of the ISO 13485:2016 standard.
ISO 13485 is required by all entities that provide products or services used by hospitals. Under EU law, all programs that handle patient data are now also considered medical devices.
Avaintec’s digital signature and workflow products, as well as our data-analysis platform, DataChief, are now officially certified medical software products.