BONEZONE: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016
Autocam Medical’s Plymouth, Massachusetts facility has been recertified to ISO 13485:2016. The scope of the certificate is “contract manufacturer of machined non-sterile medical device components and instruments, built to customer specifications.” The facility is also certified under ISO 9001.
Greg Coberly, Global Director of Quality, stated, “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.”
The recertification comes after opening a new 27,000 square foot facility in Plymouth, MA, in May. Autocam Medical’s core capabilities include CNC milling, turning, mill/turn and cutter-grinding of all surgical-grade materials, from titanium to high-performance specialty alloys and plastics.