2B1 is an Italian small company focused on design and manufacturing of medical device for Trauma and Spine applications. Some of the designed MD are placed on the market with 2B1’s own brand.
Today 2B1 is able to create a new “turnkey” medical device. 2b1 has its own resources to develop new medical devices and selected partnerships which have research and production sites.
In addition to technical expertise for the design and production 2B1 has acquired strong skills in REGULATORY and QUALITY in order to meet the requirements from the European Union for CE mark and from U.S. for FDA approval.
2B1 conducts its business according to the requirements of ISO 13485: 2003 and ISO 9001: 2008 and the EU Directive 93 / 42CEE and its updates (eg. EU Dir 2007/47 EC).
Deals with the validation of its processes, performs tests for biological controls, draw up independently in the technical files.
2B1 is able to offer to the customers a technicil service to bring a company obtain the certification of the Quality System according to ISO 9001 and IO 13485 and to draw up the technical files.
2B1 è in grado di offrire ai clienti un servizio tecnico per portare una società ad ottenere la certificazione del Sistema Qualità secondo ISO 9001 e ISO 13485 e a redigere i fascicoli tecnici.
2B1 is also working with several research centers.