04 beo en EUMM Italy

BEO BERLIN® has been closely cooperating with our Italian partner, BIOTECO s.r.l. since 2009. Bioteco (formerly Biascon s.r.l.) is a consultancy, operating since 2002, specialized in work safety and quality management on the medical market. Benefiting from their national and international network, Bioteco s.r.l. is ready to provide outstanding services for product registration and reimbursement. They gladly advise public and private sectors on health-care related issues.

“Banca Dati and Repertorio” registration:

  • Analogously to European Database (EUDAMED), mandatory registration in the Italian Database (Banca Dati – Repertorio) for all medical-device producers
  • Health-authority-required registration for Class IIa, IIb and III medical-devices (registration for Class I products is voluntary for non-Italian manufacturers)
  • Products in the Repertorio are available for hospital tenders

Respective services:

  • Consultation for Repertorio registration
  • Technical explanation or complete registration management
  • Labelling support in Italy
  • Advice in advertising medical devices according to Italian law

Quality management system (QMS):

  • EN ISO 9001, EN ISO 13485, EN ISO 14001 and BS OHSAS 18001
  • Compliance evaluation based on regional quality and environmental regulations
  • QMS-compliant personnel training
  • Business process analysis and efficient redesign

Work-environment safety analysis and training:

  • Risk assessment, such as fire risk, and exposure to chemical and biological agents
  • Writing emergency manuals and plans
  • Safety-management system analysis and implementation
  • Risk, hygiene and work-environment safety training
  • Corporate training need-determination and complete execution

For further infomration, please visit the Bioteco s.r.l. website.