
10129 Torino (TO)
Contatto: Alice Ravizza
Ruolo: CEO
Email: alice.ravizza@use-me-d.com
Telefono: +39 349 3621829
Sito
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