Kanfit 3D, Ltd., Migdal HaEmek, Israel, a manufacturer of metal additively manufactured parts, has achieved ISO 13485:2016 and ISO9001:2015 certification following a successful review conducted by the Standards Institution of Israel. The company produces parts primarily in 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 are intended to verify that a company implements stringent industry standards concerning the safety and reliability of its products, as well as the required risk management procedures. Samuel Rosenbaum, Kanfit 3D’s General Manager, stated, “We are very proud of this first-time achievement. 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.”
The company reported that is in the process of expanding its product offerings and market opportunities by adding aluminium materials to its metal AM capabilities for the aerospace, medical and high-tech industries. Two new machines are also being added to support its new manufacturing line.