C11 – Demystifying ISO 13485 and other medical devices standards

Part of Standards Australia’s role is to meet Australia’s need for contemporary, internationally aligned Standards and related services. This session will look at that role and the organization’s activities in the context of medical devices. Following on from this broad introduction, speakers will start to unravel the requirements and relevance of a selection of standards including ISO 13485. Which standards are relevant, when are these standards required to be implemented, and how do companies ensure compliance?

Chairperson: Sonja Cuce, Belsyme