Sandvik Titanium Powder Plant Achieves ISO 13485:2016 Medical Certification
Certification at Sandvik’s new powder plant in Sweden will enable medical manufacturers to 3D print implants.
Posted: September 18, 2020
Sandvik’s new powder plant in Sweden recently received the ‘ISO 13485:2016’ medical certification for Osprey titanium powders and is 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, vice president and head of Global Sales, Additive Manufacturing division.
Earlier this year, the same powder plant also achieved ‘AS9100D’ aerospace certification.
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