Pioneer Metal Finishing Achieves ISO 13485 Medical Device Certification

Pioneer Metal Finishing is pleased to announce ISO 13485 Certification of its Medical Center of Excellence facility in South Bend, Indiana.

Pioneer’s primary focus is the application of sterilization-resilient aluminum anodizing and high-performance wear and lubricity surfaces.

“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 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.” He added, “We’re thrilled to expand our capabilities in this important market.”

Corey Strege, Pioneer’s Medical Device Leader and CCO, noted, “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 this is vital to Pioneer’s customer value proposition: optimizing clinical performance while reducing risks associated with surface finishes.

Pioneer, with locations in seven U.S. states and Mexico, has been serving customers for more than 75 years, offering a range of processes including anodizing, plating, adhesive & coating applications.

Source: Pioneer Metal Finishing

JAV

Julie A. Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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