Certifications

We are attentive to the production, design and quality of our equipment. All this is guaranteed by our certifications:

• The 100% Made in Italy brand aims to confirm the value of the quality product of true Italian origin. Who does not make a valuable product made entirely in Italy will never be able to show 100% Made in Italy certification.
• ISO 13485 Medical Devices (Quality Management Systems) is a harmonised standard according to Directive 93/42/EEC and s.m.i., specifies the requirements for a Quality Management System that allows an organisation to demonstrate its ability to provide medical devices and related services that comply with customer requirements and regulatory requirements applicable to such medical devices.
• Directive 93/42/EEC lays down the conditions for the placing on the market of medical devices with a view to ensuring the safety and protection of patients' health, users and any third parties during the use of such products.