Commitment to Quality with ISO 13485

November 20, 2024, Hopkinton, MA.

Tri-Star Design has successfully renewed our ISO 13485:2016 Medical Device Quality Management System (QMS) certification. 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. By renewing this certification, Tri-Star Design will continue to support customers in the Medical Device sector.

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.