ISO 13485:2016

Medical Device Software Life Cycle Management

The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing software and standalone software which are considered as medical device in line with the Article 2 of the MDR. EN/IEC 62304:2006/A1:2015 is a basis standard which defines requirements for Medical Device Software Life Cycle Processes. In addition …

ISO 13485 Quality Management System

ISO 13485:2016 is a quality management standard for medical devices. This standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory changes which occurred since the second revision of the standard. On the other hand, this 2016 revision brought requirements closer to the US FDA expectations, …