Engineering and materials firm Sandvik Group has obtained ISO 13485:2016 medical certification for its powder plant in Sandviken, Sweden and its Osprey brand of titanium powders, enabling the company to use the material in additive manufacturing of medical products.
“Achieving 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,” said Keith Murray, vice president and head of Global Sales in Sandvik’s Additive Manufacturing division, in a company release.
Sandvik inaugurated its new powder plant in Sandviken in late 2019. The facility received AS9001D certification for aerospace earlier in 2020.
“Now we are one of the few metal powder and additive manufacturing companies that holds both the AS9100D quality certification for aerospace and the ISO 13485:2016 certification for medical,” Murray said. “This will facilitate many customer collaborations going forward.”
The powder production site has also received ISO 9001, ISO 14001, and ISO 45001 certification since opening.