Graftys achieved CE recertification in Europe and the certification of its Quality Management System in Australia, Brazil, Canada and the U.S. for the design, manufacture and distribution of its sterile calcium phosphate resorbable bone void fillers and related delivery systems.
The company's products include high viscosity Graftys QuickSet (pictured above) and lower viscosity Graftys® HBS to facilitate remote injection in close cavities. The latter is only available in Brazil.
"By achieving the MDSAP certification and the CE recertification of our bone cements,
we continue our commitment to reach the highest Quality Assurance standards and
to strictly comply with local laws and regulatory requirements in all jurisdictions we are
operating in, including Europe, North and South America, for the benefits of our
partners, our surgeons and most importantly our patients,” said Enrico
Bastianelli, M.D., MBA, Chief Executive Officer of Graftys.