The chart below includes each of the 8 clauses with their appropriate subclauses: Clause
Final Decommissioning and Disposal of Medical Devices.This global standard can be utilized by medical device manufactures that are in one or more of the following medical device lifecycle stages: Learn how ISO 13485 can help you attain CE Marking for your Medical Device If you wish to distribute your medical device across the European Economic Area (EEA), it is good to know that ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations. ISO 13485:2016 is an international standard for Quality Management Systems (QMS) of medical device manufacturers and providers. ISO 13485 specifies requirements for your QMS of your medical device and is designed to respond to latest QMS practices, including changes in technology and regulatory requirements and expectations. All ISO standards are reviewed every 5 years to establish if a revision is needed in order to keep it relevant for the most current marketplace. ISO 13485: 2016 is the most recent version of ISO 13485, the preceding version being ISO 13485: 2003. ISO stands for International Standards Organization, and covers best practices that are globally recognized by several medical device markets around the world. In this blog we will do a complete breakdown of ISO 13485:2016, leaving you feeling confident and empowered to take the next steps with your medical device! If ISO 13485 solely sounds like a random assortment of letters and numbers, don't worry, you are not alone and have come to the right place! An easily digestible overview of ISO 13485 and how it applies to your medical device company.