PROTOTYPE TODAY: Autocam Medical’s Plymouth, MA Facility Recertified to ISO 13485:2016

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.”

Autocam Medical’s Plymouth, Massachusetts division has also been named a Manufacturer of the Year by the Commonwealth’s Manufacturing Caucus. The company was nominated by State Representative Matt Muratore of the First Plymouth District. The award was established to highlight and honor successful manufacturers that represent innovative and revolutionary manufacturing capabilities and products. Autocam Medical employs 102 people at its Plymouth facility and produces high precision implants and instruments for Orthopedics and Spine, as well as precision machined components for other surgical and diagnostic applications.

“We are honored, humbled and gratified by this award,” commented John Kennedy, President and CEO. “The credit clearly goes to our team members in Plymouth who have consistently met the demands of constant technology change and taken our facility to the highest levels of quality and efficiency in the products we manufacture there.” Kennedy also pointed out that the location has recently been recertified to ISO 13485 standards, the comprehensive quality management systems for the design and manufacture of medical devices.

The 2nd Annual Manufacturing Awards ceremony was held on October 24th at the State House Grand Staircase with the keynote address given by Lieutenant Governor Karyn Polito.

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