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.

Mission

BIONEN`s mission for the future is to be the best choice for its customers, partners and workforce. BIONEN aims to achieve this through the further development of a business model capable of innovation and strong links with the territory in which it operates.

Bionen s.a.s Downloads

Bionen - Subdermal Needle Electrodes with Flat Cable - Brochure

Bionen - Model - Concentric Needle Electrodes - Brochure

Bionen - Removable Subdermal Needle Electrodes - Brochure

Bionen - Subdermal Needle Electrodes - Brochure

Bionen - Twisted Subdermal Needle Electrodes - Brochure

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