Pioneer Achieves Medical Device Certification

Pioneer Metal Finishing, LLC (Green Bay, WI), has achieved ISO 13485 certification for its Medical Center of Excellence facility in South Bend, IN.  

“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,” says Stephen Smith, CEO of Pioneer.  “Combined with significant investments in our team, facilities and equipment, Pioneer is well-positioned to provide our medical device customers with optimal solutions.” 

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.  

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

Strege added the certification is vital to Pioneer’s customer value proposition: optimizing clinical performance while reducing risks associated with surface finishes.