Autocam Medical (Kentwood, Mich.) announced that its Plymouth, Mass. facility was recently certified to ISO 13485:2016.
The surgical implants, instruments and related products manufacturer showed that its quality system was effectively implemented and maintained in order to be ISO 13485 certified.
“This recertification indicates our continued investment in a quality management system which ensures process control, accurate reporting and traceability,” Greg Coberly, global director of quality, said. “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.”