Company

BIONEN is an Italian company manufacturing accessories for neurophysiology since 1989.
The complete product portfolio is designed and manufactured in Italy and mainly includes needles and surface electrodes to perform neurophysiological examinations, like muscle activity registration (EMG) and brain activity registration (EEG).
Our team is flexible, skilled and ready to manufacture custom products to satisfy all needs of our customers.
Bionen

Quality

Our Company Quality System complies with the European Standard ISO 13485:2012 which specifies the guidelines for application of the ISO 9001 standards in R&D, design, manufacturing, installation, and service of medical devices.

All our products are CE certifiied according to the MDD 93/42/ECC and its revised version and a part of them according to the FDA Quality Systems Regulation 21 CFR.820.

We always control the bioburden contamination level of products that need to be sterilized, and to guarantee the maintainance of a minimum level of contamination some critical steps of the manufacturing process are made in a Clean Room (ISO 8).






Certifications