The management and the entire OT Bioelettronica team are committed to apply and maintain a Quality Management System that is efficient and effective in compliance with the applicable regulatory requirements and the customer needs.
All the products made by OT are compliant with the applicable European regulations (CE) relating to medical devices and already certified in accordance with EU Regulation 2017/745 (MDR) to guarantee regulatory compliance in all the phases of their life cycle: design, production, sale, installation, and technical assistance.
During 2022, OT's quality management system achieved compliance and therefore EN ISO 13485 certification for the design and production of electromyographic medical devices. The team keeps working every day to maintain certification and compliance with requirements in all processes and life stages of its products.
