Working on ISO 13485:2016 for your organization? The long-awaited handbook for all stakeholders is almost here!
ISO announced that on Monday Sept 25th, they expect to publish the ISO 13485:2016 – Medical devices – A practical guide. This handbook provides practical advice from ISO/TC 210 on the application of the standard in any organization related to medical devices, whether manufacturer, importer, or distributor. The handbook also contains useful information for all other stakeholders. Written by a small group of experts from ISO/TC 210 Working Group 1 - Application of quality systems to medical devices, this handbook brings together various guidance and best practices recognized in the industry and by regulators globally. While the standard itself was developed to be self-explanatory, experience with earlier editions has learned that supporting material with interpretation and practical solutions to meet regulatory requirements, such as provided in the handbook, is appreciated by many.