Standards and labels

• ISO 13485:2016

  Medical devices with the ISO 13485:2016 rating are tested for a quality management system that ensures consistent safety, quality, and regulatory compliance throughout their lifecycle. This provides assurance that the product is reliably produced to high international standards for patient use.

  Test results

  Medical Management Passed

  This product was made under a quality management system that ensures consistent design, production, and distribution. This focuses on the safety, performance, and regulatory compliance of medical devices throughout their entire lifecycle, from design to disposal.

• EN ISO 9001:2015

  Products from companies with the EN ISO 9001:2015 rating are tested for the company's systems for consistently providing quality products and services and meeting customer needs. This means the company is committed to consistent quality, aiming to meet your needs and improve its offerings, leading to more reliable products and better customer experience.

  Test results

  Service Reliability Passed

  This certification shows a commitment to quality and consistency. It ensures the company's processes are managed to deliver reliable, effective service and a better customer experience from start to finish.