a tradition of quality
Quality system and Certifications
Our Company Quality System complies with the European Standard ISO 13485,2016. which specifies the requirements for the design / development, manufacture, installation and service of medical devices.
All our products comply with Directive 93/42/EEC and its revised versions, for CE marking and a part of these to the FDA Quality Systems Regulation 21 CFR.820.
For an effective guarantee of the control of the level of contamination of the devices, we carry out a part of the production process in a controlled environment (ISO 8 Clean Room) and constantly monitor the level of contamination of both the work environments and the devices in the pre-sterilization phase.
2019 is the year of 30 years since the foundation of BIONEN.
We are trying to expand our presence in the international market with the support of esteemed and qualified retailers.
BIONEN obtains the FDA Clearance for its main products, the Needle Electrodes for EMG and EEG
Monia and Barbara join their father's company and contribute to the growth and international reputation of the brand which now exports to over 30 countries with a network of qualified distributors.
BIONEN moves to the new headquarters with cutting-edge services such as the ISO 8 Clean Room, ensuring better control of the contamination of the devices produced.
The 1990s are a decade of growth and significant changes for the medical device market that influence BIONEN's production and quality policy. In 1998 we obtained quality system certifications according to ISO standards.
In 1989 BIONEN was born, specialized in design, production and marketing of medical devices for neurophysiopathology.
The first company made its first debut in 1984 as the sprout of Carlo Nencioni's initiative and his experience in the field of neurophysiology as a technician at the Neurology department of the University of Florence. He has been at the helm of the company since the beginning, recognizing the need to obtain reliable tracks from bioelectric signals and sharing his managerial vision.