ISIS is ISO 13485:2016 certified, what does that mean ?
ISO 13485 is an international standard created by the International Standards Organization (ISO) for companies that design, produce, install and distribute medical devices.
With its current version known as ISO 13485:2016, market updates, technological changes and regulatory revisions are taken into account.
According to ISO, the main changes include “greater emphasis on risk management and “increased regulatory requirements for supply chain organizations.”
But it is above all the performance of the Quality Management System (QMS) and its documentation that this certification recognizes.