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| The 2016 version of ISO 13485 was published in February 2016. Become familiar with the standard's changes so your products stay on target. |
by Linda Chatwin, Esq, RAC
Manager Medical Regulatory Advisory Services
North America UL LLC
Current Status
ISO had published the final draft of the latest ISO 13485 quality management standard for medical devices, and placed it out for voting on October 29, 2015. After a two-month approval voting period, the standard was approved for official publication. For background, once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed, and only negative comments with well-reasoned, technical justification would be considered. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published.READ MORE »