Quality&Compliance » Our Certifications
After having obtained in 2002 the Approval for Quality Assurance System for production and/or sterilization, according to Annex V of EC Directive 93/42/EEC, by the "Istituto Superiore di Sanità", Notified Body N° 0373, we have endowed our company with the ISO certifications for research and development, production and trade of Medical Devices.
ISO 13485:2012 - 02.05.2016
Design, production and control of I, II and III class sterile and non sterile Medical Devices in solution, emulsion, gel, suspension, ointment and paste.
ISO 9001:2008 - 04.05.2016
Design, Development and production of Medical Devices and Nutritional Supplements. Trade and scientific information of I, II, III class sterile and non sterile Medical Devices, Nutritional Supplements and Medicines.