For more details, please see our “Quality Policy” document.
Quality
& Regulatory
We manufacture active MEDICAL DEVICES for Therapy and Monitoring.
Our goal is guaranteeing SAFETY, PERFORMANCE and EFFECTIVENESS for patients, users, and the surrounding environment.
SAFETY,
PERFORMANCE
ed EFFECTIVENESS
- devices EC certifications compliant with the applicable European Directives and Regulations;
- devices conformity to the applicable ISO/IEC/EN/CEI/UNI technical standards requirements, considering the State of the Art;
- Quality Management System compliance with the applicable requirements of the last ISO 13485 standard edition since 2000 and ISO 9001 standard edition since 1994.
- continuous monitoring and improvement of the customer and user experience of our medical devices.
Evidence of the achievement of these goals are:
