February 15, 2022

GREEN BAY, Wis.—Pioneer Metal Finishing, LLC has received ISO 13485 certification of its Medical Center of Excellence facility in South Bend, Indiana, the company said in a release.

Pioneer is an Aterian Investment Partners company headquartered in Green Bay. The company specializes in providing mission-critical metal surface engineering services to customers across a range of industries, including medical, semiconductor manufacturing, structural automotive, industrial equipment, and aerospace and defense. Pioneer offers a range of processes, from  anodizing and plating to adhesive and coating application.

Pioneer also provides R&D support to help customers develop new coating solutions that are designed to solve specific performance challenges, the company said.

“This marks a pivotal milestone in our commitment to support and grow our medical device customer base by investing in key quality management systems like ISO,” said Pioneer Metal Finishing CEO Stephen Smith, in the release. “Combined with significant investments in our team, facilities, and equipment, Pioneer is well-positioned to provide our medical device customers with optimal solutions. We’re thrilled to expand our capabilities in this important market.”

ISO 13485 certification is a critical element of Pioneer’s long-term plan to develop a Medical Center of Excellence, focused on the optimization of surface engineering applications, to provide industry-specific solutions. Pioneer’s primary focus is the application of sterilization-resilient aluminum anodizing and high-performance wear and lubricity surfaces.

“Completing ISO 13485 certification and other investments in processing equipment and production automation are essential improvements for our medical device customers,” said Corey Strege, Pioneer’s medical device leader and CCO, in the release. “We’re now able to provide solutions that align perfectly with unique FDA requirements for controlling ‘special processes’ associated with surface finishes.”

Vital to Pioneer’s customer value proposition, Strege added, is “optimizing clinical performance while reducing risks associated with surface finishes.”

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