On November 8th and 9th, our company underwent a supervisory audit of the quality management system for medical devices according to the standard DSTU EN ISO 13485:2018 “Medical devices. Quality management system. Regulatory requirements”. Specialists of the “Ukrainian Center for Medical Certification and Forecasting” checked the company’s quality system, which covers all stages – from design projects, laboratory research and production processes in workshops to the activity of logistics and the warehouse of finished products.

Having demonstrated proper compliance with standards at all stages of production, we confirmed compliance with the requirements of DSTU EN ISO 13485:2018.

Moreover, we received valuable recommendations from an experienced auditor that will help us improve the processes of the existing quality management system in accordance with European requirements. So we continue to work, grow, develop and produce only the highest quality products.