Pioneer Receives Medical Device Certification

Pioneer Achieves Medical Device Certification Pioneer Metal Finishing, LLC announced that its Medical Center of Excellence facility in South Bend, IN has obtained ISO 13485 certification. Pioneer CEO Stephen Smith stated, "This is a significant milestone in our commitment to supporting and expanding our medical device customer base by investing in fundamental quality management systems such as ISO. Combined with substantial investments in our team, facilities and equipment, Pioneer is well positioned to provide optimal solutions for our medical device customers. We are excited to expand our capabilities in this important market." The ISO 13485 certification is a critical element of Pioneer's long-term plan to develop a Center of Excellence focused on optimizing surface engineering applications to provide industry-specific solutions. Pioneer's primary focus areas are sterilization-resistant aluminum anodizing and high-performance wear and lubricity surface applications. Corey Strege, Pioneer's Medical Device Leader and Chief Commercial Officer, stated, "Completing ISO 13485 certification and finalizing additional investments in processing equipment and manufacturing automation represent fundamental improvements for our medical device customers. We can now provide solutions that achieve perfect compliance with unique FDA requirements to control 'special processes' associated with surface finishing." Strege noted that mitigating risks associated with surface finishing while optimizing clinical performance is vital to Pioneer's customer value proposition. Source