Sandvik achieves ISO 13485:2016 medical certification for its titanium powder plant
Sandvik’s new powder plant in Sweden has recently received the ‘ISO 13485:2016’ medical certification for Osprey® titanium powders, now approved for use in the additive manufacturing of medical applications.
3D printing of implants enables rapid manufacturing directly from an individual’s anatomical data – enhancing the healing process and improving the prognosis for the patient.
“Achieving the ISO 13485:2016 medical certification will allow our medical customers to complete the necessary regulatory supplier approvals when bringing a medical application to market, utilizing Osprey® titanium powders from Sandvik,” says Keith Murray, VP and Head of Global Sales at division Additive Manufacturing.
Sandvik’s titanium powder plant in Sandviken, Sweden was inaugurated at the end of 2019. Earlier this year, the same powder plant also achieved the prestigious ‘AS9100D’ aerospace certification.