Sil-Pro, a contract manufacturer of Medical Devices & Molded Medical Components, announced today that it has achieved ISO 13485:2003 certification.
ISO 13485 quality standard specifies quality system requirements to ensure consistent manufacturing of medical devices. “This achievement demonstrates our continuous improvement with this addition to our existing certification of ISO 9001:2008. Plus it exemplifies Sil-Pro’s total support to the medical device industry,” stated Kevin Carver, President of Sil-Pro. “It also reaffirms our position as a reliable supplier that is solidly focused on meeting the quality standards of our customers.”
Sil-Pro is a Medical Manufacturing Solutions Provider with a strong customer focus. The company has received awards from the medical device community in recognition of its performance as a top supplier. Notable among these is the accomplishment of being named the winner of the coveted Boston Scientific CRM Rhythm Award in 2009.
Sil-Pro’s core competencies of Silicone and Plastic Molding as well as Silicone Extrusion are supported by a staff of Automation Engineers, Tool Designers and a state-of-the-art In-House Tool Shop. These manufactured components often feed into secondary operations of pad printing, bonding, sub-assembly, final assembly and final packaging. Projects are managed by dedicated personnel in the Project Engineering and Quality Engineering departments from the prototype stage through final production release.