Press release submitted on behalf of Fabrik.
Fabrik Molded Plastics (Fabrik), a leading provider of precision plastic injection molding solutions, announced it has achieved ISO 13485:2016 certification, an internationally recognized standard for quality management systems in the medical device industry.
This certification reinforces Fabrik’s commitment to delivering high-quality, reliable plastic injection molded components to the medical sector, where consistency, traceability, and regulatory alignment are essential.
ISO 13485 establishes a framework for quality management in medical device manufacturing, focused on risk management, process control, and lifecycle product quality. For Fabrik, achieving this certification reflects a deliberate investment in systems, processes, and people to support customers in regulated environments, delivering the traceability, discipline, and repeatability required for consistent production performance.
“Achieving ISO 13485 certification is a significant step forward for Fabrik and a clear signal to our customers that we are serious about supporting the medical industry at a high level,” said Don Hardin, President of Fabrik. “This certification reflects the discipline and commitment our team brings every day to deliver dependable, high-quality components that our partners can trust.”
Fabrik’s approach combines technical expertise in plastic injection molding, including insert molding and overmolding. The company also has experience producing lighting and optical components requiring tight process control and consistency, capabilities that translate well into demanding medical applications. Fabrik further supports customers through engineering collaboration, including advanced DFM and CT scanning, helping identify risks early and improve manufacturability prior to production.
This certification strengthens Fabrik’s ability to support medical OEMs and suppliers with a structured, audit-ready quality system designed to reduce risk and ensure consistent production performance. The company is actively engaging with medical OEMs evaluating new programs, dual-sourcing strategies, or program transfers.
About Fabrik Molded Plastics
Fabrik is a precision manufacturing partner specializing in plastic injection molding solutions for customers who demand performance, reliability, and adaptability. With deep expertise in complex molding applications including insert molding, overmolding, and optical components, Fabrik supports customers across medical, automotive, and industrial markets.
Fabrik provides customer engineering support through advanced DFM and CT scanning as part of its broader capability set focused on reducing risk and improving production outcomes.
Built on a foundation of integrity, responsiveness, and continuous improvement, Fabrik works alongside its customers to solve challenges, optimize processes, and support the full lifecycle of their products from concept to production. For more information, visit fabrikind.com.