Sofemed International

SOFEMED offers high quality solutions according to international standards as ISO 13485/2016 and European directive 93/42/CEE of medical devices (soon European regulation 745/2017). We use, always, biocompatible raw material for all our ranges of implants. Our titanium is according to ISO 5832-2 and ISO 5832-3. Stainless steel is according to ISO 5832-1. All our raw material is from approved suppliers. Our purchasing process from suppliers selection to quarantine raw material management to mechanical and chemical composition analysis is according to ISO13485/2016 and risk analysis procedure. For all the steps of development and manufacturing, risk management is constantly adopted. Our process includes also clinical evaluation, implants mechanical and biological testing and raw material suppliers audits.

From the manufacturer's own website. Source