QUALITY AND COMPLIANCE
Certifications and quality
Our commitment to compliance and manufacturing excellence.
OUR COMMITMENT
Our quality system
Quality is the foundation of every one of our processes. From design to production, from distribution to after-sales support, every phase is monitored and documented according to the most rigorous international standards.
Process controls
Every stage of the production process is traceable, from raw materials to the release of the finished medical device.
Identification and Traceability
Each device is identified, traceable over time and is always accompanied by specific Instructions for Use (IFU).
Post-market surveillance
Proactive and continuous monitoring of product safety from the time they are placed on the market.
TÜV SÜD
UNI EN ISO 9001:2015 A1:2024
Quality Management System. Certifies the adoption of a management system compliant with international standards for process quality.
TÜV SÜD
UNI EN ISO 13485:2016/A11:2021
Medical Device Quality Management System. A specific standard for organizations operating in the medical device supply chain.
ITALIAN STANDARDS BODY
IT
Compliance with UNI technical standards applicable to the medical device sector for design and production.
GENDER EQUALITY
UNI/PdR 125:2022
Reference practices for gender equality. Certifies the company's commitment to inclusion, fair pay, and equal opportunity policies.
REGULATION
Regulatory compliance
All our medical devices comply with current directives and regulations governing the manufacturing of medical devices. Regulatory compliance is ensured through a post-market surveillance system and complete traceability of production batches.
CE marking
Compliance with essential safety and performance requirements
Registration
Registered in the National Register of Medical Devices and in the Eudamed Database
Technical documentation
Each device is carefully designed and validated; each product is constantly monitored throughout its life cycle.
Post-market surveillance and vigilance system
Continuous monitoring of product safety and field performance.
