What is the current version of ISO 13485? The latest revision of ISO 13485 for ISO medical devices is from March 2016. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facil...
. Storing, tracking, and updating paper records becomes too costly and time-consuming as the volume continues to rise. The transition to remote work practices also makes it nearly impossible to keep paper records in a centralized location and ensure everyone is working from the latest revision....
The latest revision of ISO 13485 for ISO medical devices is from March 2016. Among the additions to this update are included: a focus on risk, clarification of management responsibilities, clarification of training responsibilities, improvement to the facility requirements, better alignment of design a...