Specialist Neurophysiology Manufacturer Since 1989
BIONEN designs and manufactures electrodes and accessories for neurophysiology in Florence, for its own brand and OEM partners. We combine technical expertise, in-house manufacturing and direct relationships with customers and international partners.
Who we are
BIONEN is an Italian manufacturer of neurophysiology accessories. In Florence, we design and manufacture electrodes and accessories for the main applications, including EEG, EMG/NCS, evoked potentials, polysomnography and intraoperative neurophysiological monitoring.
Founded in 1989, BIONEN is an Italian family-owned company, now led by the second generation of the Nencioni family.
Our technical, manufacturing, quality and commercial teams work closely together, allowing us to maintain direct control over our products and close relationships with customers, distributors and international partners.
Quality & Compliance
BIONEN quality is built on direct process control, in-house expertise and a structured quality system based on the standards applicable to medical devices.
BIONEN’s Quality Management System is certified to ISO 13485, and our devices comply with the applicable requirements of Regulation (EU) 2017/745 (MDR).
The manufacture of sterile devices includes activities carried out in an ISO Class 8 cleanroom, within controlled and qualified processes.
BIONEN also holds product registrations in a number of international markets, in accordance with applicable local regulatory requirements.
Download our certifications
Our Story
1984
THE BEGINNING
Carlo Nencioni starts the entrepreneurial project that will later become BIONEN, bringing his experience in neurophysiology and a strong focus on signal reliability into product development.
1989
BIONEN IS FOUNDED
BIONEN establishes its own identity and specialises in the design and manufacture of electrodes and accessories for neurophysiology.
1998
QUALITY BECOMES A SYSTEM
BIONEN formalises and certifies its Quality Management System according to the international standards applicable to medical devices.
2005
THE SECOND GENERATION
With Monia and Barbara Nencioni joining the company, BIONEN strengthens its organisation and accelerates its international growth.
2012
INTERNATIONAL EXPANSION
BIONEN strengthens its presence in international markets, developing new partnerships with distributors and OEM partners.
2019
30 YEARS OF BIONEN
In 2019, BIONEN celebrates 30 years since its founding, consolidating its international presence and relationships with distributors and partners across key markets.
2023
MDR TRANSITION
In 2023, BIONEN begins its transition to Regulation (EU) 2017/745 (MDR), achieving certification for the first device families and progressively bringing its product portfolio into compliance with the new Regulation.
Today
NEW MARKETS
Today, BIONEN continues to strengthen its international presence in more than 110 countries and develops new partnerships with distributors and OEM partners, with the aim of growing in new markets while keeping Florence at the heart of its manufacturing operations.
1984
1989
1998
2005
2012
2019
2023
Today
MISSION
To design and manufacture neurophysiology electrodes and accessories in Italy that healthcare professionals and partners can rely on.
We work directly with those who use, distribute or integrate our products, combining specialist expertise, process control and the ability to turn real-world requirements into viable solutions.
Vision
To be the specialist manufacturer that professionals and partners worldwide turn to for neurophysiology accessories.
We want to grow without losing what makes BIONEN distinctive: application knowledge, direct accountability, manufacturing quality and the ability to adapt.
OEM SOLUTIONS FOR MEDICAL DEVICES
BIONEN supports distributors and partner companies in the development and OEM manufacture of medical devices, providing design, manufacturing and regulatory expertise.
Neurophysiology is our main area of specialisation, but the know-how developed over more than forty years is also applied to selected projects in other medical fields.
From adapting existing products to dedicated configurations and partner-branded solutions, we work with a direct, flexible approach focused on technical and manufacturing feasibility.
Sustainability: Environment & People
For BIONEN, sustainability means integrating environmental responsibility and care for people into the way we manufacture and work.
In recent years, we have reduced the environmental impact of our processes through the use of electricity from renewable sources, reduced of plastic in our packaging and the increasing digitalisation of activities and documentation.
The same commitment extends to our people. We promote a working environment based on expertise, respect and equal opportunities, with a balanced representation of women and men across the organisation.
Our Sustainability Report brings together the data, initiatives and objectives that describe this journey.
100%
electricity from renewable sources
–99%
plastic in packaging
–90%
paper consumption
50% – 50%
women and men across the team