Original Date: April 8, 2020 – Amplify Additive of Scarborough, Maine received ISO 13485 Certification
Amplify Additive is pleased to announce that the company has received its ISO 13485 certification for Contract 3D Metal Printing (additive manufacturing) of orthopedic implant components.
“For contract manufacturing, this represents a growth market and an opportunity to work with engineering and design teams across the US and around the globe,” says Brian McLaughlin, President & CEO of Amplify Additive.
ISO certification is established through the International Organization for Standardization (ISO) and includes U.S. Food and Drug Administration’s Good Manufacturing Practices. Certification is a rigorous process. Certification demonstrates a documented 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. McLaughlin states: “For our team, it opens the door to new collaborations and projects in the world of orthopedic implant manufacturing.”
Amplify Additive, located in Scarborough, Maine is using 3D printing technology called 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 states: “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.”