Kanfit 3D, Ltd. announced that it has achieved ISO 13485:2016 and ISO9001:2015 certification following a successful review conducted by the Standards Institution of Israel. Kanfit 3D is a leading manufacturer of high-quality metal parts using laser sintering of metal powder—specifically Ti-64— for the aerospace, medical and dental industries.
ISO 13485:2016 is the international standard for quality management systems specifically for medical device manufacturers and their suppliers, while ISO9001:2015 ensures that services and products meet the needs of all clients through an effective Quality Management System. These certifications verify that Kanfit3D implements stringent industry standards concerning safety and reliability of its products as well as the required risk management procedures.
“We are very proud of this first time achievement,” said Samuel Rosenbaum, General Manager of Kanfit 3D. “As a young company, earning both ISO certifications is a great accomplishment. It shows our commitment to deliver the highest level of regulatory compliance and quality products to our customers in all industries.”
Kanfit 3D is in the process of expanding its product offerings and market opportunities by adding aluminum materials to its already successful Ti-64 AM capabilities for the aerospace, medical and high-tech industries. Two new machines are being added to support its new manufacturing line.