SurgiBox obtains the ISO 13485:2016 Certification

Striving to provide the ideal of safe surgery anywhere with high quality and consistently safe products, SurgiBox has successfully implemented a quality management system that meets the requirements of the ISO 13485:2016 standard. ISO 13485 is a globally accepted standard for creating and regulating quality management systems of medical device manufacturers internationally. It is considered a sign of a good quality system in the USA, Europe, Japan, Australia, SIngapore, and Canada among others - and is even a requirement to market medical devices in some! It enables the certified company to have a quality system that emphasises risk management in relation to the safety and performance of medical devices as well as ensuring compliance with internationally accepted medical and regulatory safety standards. ISO 13485 Certification resulted from the completion of a successful evaluation of SurgiBox’s quality management system by DNV, an internationally accredited registrar based in Norway.