Tri-Star Design, Inc. Receives ISO13485:2016 Certification for Design and Development of Medical Devices

November 12, 2021, Hopkinton, MA

Tri-Star Design, a recognized leader in the design of medical, robotics, industrial and defense products, announced today that it has received ISO 13485:2016 certification for their Medical Device Quality Management System (QMS). Companies that achieve ISO 13485:2016 certification must meet the stringent product safety, reliability, and quality requirements of the International Organization of Standardization (ISO). ISO 13485:2016 certification involves demonstrating best practices throughout all stages of a medical product’s design and development cycle.

“Our staff are excited and proud to receive this highly coveted certification,” said Randall McDonald, President and CEO of Tri-Star Design, Inc. “This certification represents an important achievement for Tri-Star and reflects the commitment we have on process decision making throughout our organization with a dedication to safety and providing a high-quality product.”

ISO 13485:2016 certification is recognized throughout the international medical device industry. The QMS under this certification defines audit, management review and continuous improvement processes focusing on solving customer needs thereby providing more expedient medical product design execution with increased satisfaction.


Please contact Tricia Shamus, at for additional information.