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