Quality is a technical aspect that involves all aspects of corporate life.
This is why we comply with all international regulations and with the highest certification standards.
Since December 2009 Microgate is officially accredited by the certification body DNV-GL in compliance with the requirements of the standard for quality management systems UNI EN ISO 9001:2015
Microgate decided to certify all four sectors, Professional Timing, Training&Sport, Medical as well as Engineering, as shown in the Field of Application of the certification:
Design, development, manufacturing and trade of professional timing systems for sport applications and performance analysis.
Design, development and Manufacturing of real-time control systems for industrial and astronomical applications. Design, development and manufacturing of medical devices for biomedical analysis, functional rehabilitation and injury prevention.
(EA: 19, 29)
The Quality Policy of Microgate S.r.l. is oriented towards planning and realization of quality products with high technological content and performance: innovation and design are essential elements of corporate strategy development.
In this context, the organization has chosen to adopt a certified quality management system in accordance with UNI EN ISO 9001:2015 as a tool for improving its performance, process control, and customer satisfaction.
Since December 2011 Microgate is officially accredited by the certification body DNV-GL 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.