Mitelos renews ISO 13485:2016 certification for medical devices

Mitelos renews ISO 13485:2016 certification for medical devices

Mitelos, a leading medical device manufacturer, is proud to announce the renewal of its ISO 13485:2016 certification. This certification demonstrates Mitelos’ commitment to providing high quality medical devices that meet the rigorous standards set by the International Organization for Standardization (ISO).

ISO 13485:2016 specifies the requirements of a quality management system in which an organisation must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

«We are delighted to have renewed our ISO 13485:2016 certification,» said Esther Soler, Regulatory Affairs and Quality Assurance Manager at Mitelos. «This achievement is a testament to our dedication to providing safe and effective medical devices to our customers. We will continue to strive for excellence in all aspects of our business.»

The renewal of Mitelos’ ISO 13485:2016 certification is just one example of the company’s ongoing commitment to quality and safety in the medical device industry.