For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will be published in spring 2016.
The changes aim to more holistically address the entire medical device lifecycle and supply chain. Some key points of emphasis include supplier controls, quality feedback processes, software controls, integration of risk management in the QMS, clarifications of design verification and validation, and general harmonization with regulatory requirements.