The New ISO 13485:2016 – Overview & Key Changes

ISO 13485:2016 is the international standard that defines quality management system requirements for organisations that design, develop, manufacture, install and service medical devices as well as design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices.

In this two-part interview Susan shares her thoughts on the new ISO 13485:2016 medical Quality Management System (QMS) standard, and how it impacts manufacturers.