ISO 13485:2016 Certification

Melsytech’s quality management system successfully completed ISO 13485:2016 certification for development and production of solid state laser systems, semiconductor lasers, and electronic devices for medical application. The certificate was issued by a Czech notified body. The certification confirms our ability to manage risks during production and operation of medical devices, and thus ensure safe experience for doctors and patients using our devices. The certification is our next step towards CE marking and marketing of devices in EU.