ISO 13485:2016 Medical devices - Quality management systems 

Since December 2011 Microgate is officially accredited by the certification body DNV in compliance with the requirements of the standard for quality management systems UNI EN ISO 13485:2016.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Our product OptoGait was developed according to these rules and has already been inserted in the Register of Medical Devices of the Italian Ministry of Health.