{"id":4305,"date":"2021-10-21T07:36:36","date_gmt":"2021-10-21T07:36:36","guid":{"rendered":"https:\/\/ias-certification.com\/?p=4305"},"modified":"2026-06-11T06:50:39","modified_gmt":"2026-06-11T06:50:39","slug":"iso-13485-medical-devices","status":"publish","type":"post","link":"https:\/\/ias-certification.com\/ca\/blog\/iso-13485-medical-devices\/","title":{"rendered":"ISO 13485 Medical Devices"},"content":{"rendered":"

ISO 13485 Medical Devices<\/h1>
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About ISO 13485 for medical devices<\/span><\/strong><\/h2>\n

ISO 13485 is an international standard for manufacturers and certifiers of medical devices. When a device is described as meeting ISO 13485, it means it has been made following the requirements of the standard. ISO 13485:2016 specifies the requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements and, where relevant, patient safety goals.<\/p>\n

The ISO 13485:2016 version<\/strong><\/span><\/h3>\n

The most recent revision of ISO 13485 was published in March 2016. ISO 13485:2016 is a major update from ISO 13485:2003, published to reflect changes in regulation and technology, improve clarity, and align with ISO 9001 and other requirements.<\/p>\n

\"ISO<\/p>\n

What is a medical device?<\/span><\/strong><\/h3>\n

ISO 13485 defines a medical device as an instrument, apparatus, appliance, software, material, or other article intended by the manufacturer to be used on humans for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Examples include:<\/p>\n