News

These are some of the news that our daily activity generates in Naru Intelligence.

Naru Intelligence is ISO 13485 certified

After months of hard work, Naru Intelligence has obtained the certification of its Quality Management System (QMS) according to ISO 13485 for the design and development, production, installation and service of softwre medical devices. The certification has been carried out together with the Centro Nacional de Certificación de Productos Sanitarios (CNCps), whose excellence is guaranteed by more than 25 years of experience in the sector.

The ISO 13485 standard is considered a benchmark in the implementation of QMS, a basic aspect for the CE marking of medical devices according to the European Regulation MDR 2017/745. First published in 1996 by the International Standards Organization (ISO), it is a specific adaptation for medical device manufacturers of the internationally recognised ISO 9000 set of standards.

Since 2017, Naru has been committed to a solid regulatory strategy, in order to offer technology in accordance with the highest standards of quality and efficiency from the conception of our products and throughout their lifecycle. At Naru, we provide added value to our customers and end users, meeting their expectations through the compliance with the regulatory requirements applicable to medical devices. Following these maxims of excellence, safety and continuous improvement, Naru placed its first two software medical devices in the market by May 2021.

Being ISO 13485 certified is a particularly important milestone for Naru, as it brings us one step closer to certifying our technology under the European Regulation MDR 2017/745 and reinforces our commitment to developing quality, safe technology with the highest performance and satisfaction for our end-users and customers.

3 Key Words: Medical Device, MDSW, MDR 2017/745, ISO 13485