(GRAND RAPIDS, MI)—August 1, 2017—Autocam Medical, a global contract manufacturer of surgical implants, instruments and related products, has announced its Plymouth, MA facility has been recertified to ISO 13485:2016. ISO 13485 requires that the certified organization demonstrate the quality system is effectively implemented and maintained. The scope of the certificate is “contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.”
According to Greg Coberly, Global Director of Quality, “This recertification indicates our continued investment in a quality management system which ensures process control, accurate reporting, and traceability. This approach dramatically improves manufacturing integrity, reduces lead time, and provides the most reliable and high quality medical device components for our customers. This facility is also certified under ISO 9001, the quality management standard that demands a relentless focus on continuous improvement.”
About Autocam Medical
Autocam Medical is a global contract manufacturer of precision-machined surgical drill bits, drivers, screws, plates, cutting tools and other complex, highly engineered surgical implants, instruments, and handpieces, as well as other device components. Our clients are involved with instruments and devices used in the following anatomical areas: foot and ankle, hand and wrist, hip and knee, shoulder and elbow, spine, and craniomaxillofacial procedures. We offer a value-added approach to high-precision manufacturing, with specialties in CNC milling, turning and cutter grinding. State-of-the-art equipment and design for manufacturing engineering add value to the entire manufacturing process. ISO13485/ISO 9001, FDA Registered, VISA (Brazil). Facilities in the U.S., China and Brazil.