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.
WEEE Compliance Statement
The European Union has adopted Directive 2024/884 on waste electrical and electronic equipment (WEEE), with requirements went into effect on April 8, 2024. This directive aims to reduce the disposal of waste electrical and electronic equipment by establishing guidelines for prevention, reuse, recycling, and recovery.
In compliance with our legal obligations, OT Bioelettronica is now a registered producer of EEE. Our WEEE registration number is IT24050000016096. For more information on the proper disposal of our equipment, marked with the label below, please contact us.
Battery and Accumulators Compliance Statement
The European Union has adopted Regulation (EU) 2023/1542 on batteries and accumulators and waste batteries, whose requirements entered into force on 18 February 2024. This regulation aims to reduce the environmental impact of batteries and accumulators by establishing guidelines for their collection, recycling, and safe disposal.
In compliance with our legal obligations, OT Bioelettronica is now registered in the National Register of Batteries and Accumulators. Our registration number is IT26030P00012079.
For further information on the correct disposal of the batteries and accumulators supplied with our products, please contact us.
