Pioneer Achieves Medical Device Certification
Pioneer Metal Finishing’s South Bend, Indiana based Medical Center of Excellence facility has achieved ISO 13485 medical device certification.
![surgical tools](https://d2n4wb9orp1vta.cloudfront.net/cms/brand/PF/2022-PF/pfnews022322pioneermed2.jpg;maxWidth=385)
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.
Related Content
-
Finishing Systems Provider Celebrates 150 Years, Looks to Future
From humble beginnings as an Indiana-based tin shop, Koch Finishing Systems has evolved into one of the most trusted finishing equipment providers in the industry.
-
Deoxidizing Aluminum as a Pretreatment
This important first step can help prepare the metal for subsequent surface finishing.
-
Understanding and Managing White Spots on Anodized Aluminum
Having trouble with spotting defects when anodizing? Taj Patel of Techevon LLC offers a helpful overview of the various causes of white spots and potential solutions.