ISO 9001:2015

Quality management system to conduct business processes, improve the effectiveness and efficiency regarding both product realization and service provision, obtain and enhance customer satisfaction.

ISO 13485:2016

Standard for the quality management system specific to companies in the medical sector, it includes aspects of the ISO 9001 standard and specific requirements for the medical device sector.

ISO 62366 Usability Engineering

Process-based standard, which aims to help medical device manufacturers to design in a highly usable manner. Devices designed in compliance to this standard, guarantee extreme user-friendliness and the impossibility of performing dangerous actions

Documentation is available upon request

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CEI EN 60601.1.2

This Standard’ scope includes safety, essential performance and the electromagnetic compatibility of electromedical equipment and systems. Compliance with this standard is essential to accessing operating rooms and critical areas. Full report is available upon request

CEI EN 61010.1

Technical standards for the safety and essential performance of electro-medical equipment. Essential to ensure the safety of operators and patients. Full report is available upon request

ISO 14155.1.2

Clinical practice for the design, execution, registration and demonstration of clinical investigations conducted on human subjects, in order to evaluate the safety or performance of medical devices for regulatory purposes. Several clinical tests and subsequent follow-ups guarantee the effectiveness of our devices

Regulation 745/2017

Our devices already comply with the new European regulation 745/2017, which will obligatorily replace the old regulation 93/42, as to ensure greater safety and effectiveness of the devices

Seal of Excellence

“Seal of Excellence” is a quality mark awarded by the European Commission to excellent and positively evaluated Research and Innovation project proposals submitted in response to the Horizon 2020 notice. Such recognition (only 0.2% of medical companies in Europe received it) allows us to further prove the very high quality of our products