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Amplify Additive Gained ISO 13485 Certification

The certification is for contract 3D metal printing (additive manufacturing) of orthopedic implant components.

By: Amplify Additive

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,” said Brian McLaughlin, president and 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. It 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 stated: “For our team, it opens the door to new collaborations and projects in the world of orthopedic implant manufacturing.”

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