Overview:
Bionen has been an Italian manufacturer of electrodes and accessories for neurophysiology since 1989. The entire product portfolio is made in Italy and mainly includes needle and surface electrodes for the detection and measurement of brain (EEG) and muscle (EMG) activity. Bionen can create custom products to meet all customer needs.
The Company Quality System conforms to ISO 13485:2012 and ISO 9001 standards in the design/development, manufacture, installation and service of medical devices. All products comply with Directive 93/42/EEC and subsequent amendments for CE marking, and part of them with FDA Quality Systems Regulation 21 CFR. 820. To ensure effective control of the level of contamination of the devices, part of the production process is carried out in a controlled environment (ISO 8 cleanroom).
