SteriLux has received ISO 13485:2016 certification

We are excited to announce that SteriLux has received ISO 13485:2016 certification for Medical Device and Quality Management Systems from Lloyd’s Register. This ISO certification indicates that the company’s quality management system meets the most current regulatory requirements specific to the medical device industry.

“We are very proud to have received this certification which demonstrates our commitment to quality and is a key step to obtaining the CE marking approval of our product” explains Lucas Meyer, CTO of SteriLux and in charge of quality management.

ISO 13485:2016 is an internationally recognized quality standard for a quality system to ensure customer and regulatory requirements are consistently met throughout the lifecycle of the medical device product.