ISO 13485:2016 

Apply For Services

ISO 13485:2016 is an international standard that outlines requirements for quality management systems in the medical device industry. It was published on February 25, 2016.

SO 13485:2016 is an international standard that specifies the requirements for a quality management system (QMS) specifically for medical devices and related services. It is designed to help organizations ensure that they meet both regulatory requirements and customer expectations for the safety and effectiveness of medical devices.