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
