Product Certification
The products we assemble are certified by international standards (CE, FCC, and others) in order to guarantee reliable and safe products for our customers and to be in accordance with the law.
All the circuits are conformal EN 55032 (2012 or greater) Electromagnetic compatibility (EMC) of multimedia equipment – Emissions requirements, EN 55024 (2010) Information technology equipment – Immunity characteristics – Limits and methods of measurement and they are subject to the CE mark of conformity. All the medical devices are tested following the EN 60601 and the ETSI EN 300-301 in order to assure the maximum quality and safety to our medical devices production.
Thanks to the test equipment we have in our plant, including a thermal chamber, we are able to independently carry out various tests on the devices we develop and assemble, and this allows us to offer this kind of service to our customers also, if requested.
We support our customers by carrying out the laboratory tests necessary for the CE certification of electrical and electronic devices and by drawing up the technical file in order to issue the CE Certificate for the EMC and R&TTE Directives.
Contact us if you need a partner to carry out trial tests on your products, accompanying you along the path to obtain the CE certification.
ISO 9001:2015 & ISO 13485:2016
We are constantly improving our quality management system by monitoring the different operating procedures to optimize our processes and improve our services.
The Quality is the base of our success so we make continuous investments.
Thanks to our experienced and proven quality system we already:
- MONITOR OUR SUPPLIERS
- MONITOR GOODS IN AND OUT
- MONITOR OUR INTERNAL PROCESSES IN ORDER TO CONSTANTLY OPTIMIZE THEM
- CONSEQUENTLY, OFFER OPTIMIZED AND QUALITY PRODUCT AND SERVICES TO OUR CUSTOMERS
Our Quality Management System, therefore follows every EMC activity, from the choice of suppliers, to after-sales services, to the personnel management. Our mission is to provide customers with accurate and reliable solutions and services responding to their needs, while maintaining a work environment in which each employee has the necessary skills to understand and master the work required by their job.
Medical Devices
We are now registered in EUDAMED database as manufacturers of Medical Devices (SRN RO-MF-000035074).