Amplify Additive Receives ISO 13485 Certification

Amplify Additive TibTray Samples

Amplify Additive received its ISO 13485 certification for Contract 3D Metal Printing/additive manufacturing of orthopedic implant components.

ISO certification demonstrates a quality management system throughout the company. The Stage 2 Audit for ISO certification was completed in January 2020, and the team was recommended for certification at that time.

Amplify Additive uses Electron Beam Manufacturing (EBM) to create implants for orthopedic patients, saving both time and money and improving clinical outcomes. Scans that come directly from an orthopedic setting can be uploaded, designed and built to a patient’s unique clinical needs. Turn-around time is quick, and in the field of orthopedics, Amplify’s advanced technology is impacting lives in a positive way.

President and CEO Brian McLaughlin said, “We often act as the bridge between two very different disciplines – orthopedic surgeons and design engineers. Teams often have a shared vision, but uncertainty about how best to implement additive manufacturing (3D Metal Printing with EBM). This can sometimes present hurdles to overcome. We’re able to use our expertise on both sides of the aisle, to add value and offer organizations a solution to overcome those hurdles. We implicitly understand both sides of the conversation.

“The orthopedic community is a beacon for using additive manufacturing to drive innovation, from the concept stage, all the way through to the volume production of implants. Continued education about our process of Additive Manufacturing and EBM will only empower surgeons and engineers to push boundaries further in 3d metal printing.”

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