QUALIA™NEOACTIVE

Qualia™NeoActive implants are made of extra-high-tension grade 4 titanium which gives it a substantial improvement in its elastic limit and mechanical prop-erties, as well as keep the compliance with the re-quirements of Standards and Certificates according to the requirements of the Medical Directive 93/42/EEC and its amendment 2007/47/EC by the 0051 notified body. The Qualia™NeoActive implants are sterilized by Beta Rays irradiation at 25kGy.

BIOSTAR® Laboratories, SLU has the manufacturer’s license for medical devices and the commercial authorization by the AEMPS 6425-PS (Spanish Agency for Medicines and Medical Devices). Our quality management system is certified according to the requirements of the UNE-EN-ISO 9001:2015 and UNE-EN-ISO 13485:2016 standards, also complying with the requirements of GMP 21 CFR 820.