COMPANY2B1 was born in early 2004 to “collect” ideas from the market to create an Italian structure able to design and manufacture medical devices.
2B1’s attention is focused on devices with these three basic requirements at least:
– to be innovative
– to be original
– to have a strong appeal to niche markets
2B1 has obtained good results over time.
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.
The main areas of activity and experience are related to:
– SPINE e
2B1 already boasts international partners, leader in the worldwide market
THE IMPORTANCE OF QUALITY ‘IN THE DESIGN AND PRODUCTION OF MEDICAL DEVICES
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.
2B1 has a Research & Development Unit in Sardinia, Reserches in Pula, the Science and Technology Park of Sardinia, born by the joint commitment of the Autonomous Region of Sardinia and the European Union.