USE-ME-D srl


Campus Politecnico di Torino
C.so Castelfidardo 30/a, TORINO
10129 Torino (TO)


Contatto: Alice Ravizza
Ruolo: CEO
Email: alice.ravizza@use-me-d.com
Telefono: +39 349 3621829

Anno di Fondazione: 2018
Impiegati: 4
Impiegati R&D: 5
Settori di attività: Medical devices / Biotech Healthcare

Keywords:
Usability, Medical Device Regulation, Biomedical safety

DESCRIZIONE

Our services premarket:

  • Design control and strategic approach to regulatory requirements
  • Review/preparation of technical documentation (Technical
    • Risk management: ISO 14971
    • Clinical Evaluation report
  • Implementation of the Quality Management System in compliance with UNI EN ISO 13485

Our services clinical and usability trials:

  • Design of device specific clinical trials for regulatory compliance
    • Ethics committee relations
    • Privacy & GDPR
    • Monitoring
    • Reporting

Our services Usability:

  • Usability studies
    • Formative evaluation
    • Summative evaluation
    • Analysis of results
    • Report drafting In compliance with IEC 62366

Our services post market activities:

  • Post market strategies and procedure
  • Proactive collection of post market information
    • clinical
    • user experience
  • Reporting and change control

Regulatory:

  • Notified Body relations
  • Role of Person Responsible for regulatory compliance as requested by Regulation (EU) 2017/745
    • accredited at AICQ Sicev