TT Electronics achieves ISO 13485 certification at Mexicali facility
TT Electronics has announced that its EMS facility in Mexicali, Mexico, has been certified to the ISO 13485:2016 standard — an internationally recognised quality management system for medical device manufacturing.
The certification signals compliance with stringent regulatory and customer requirements for the design and production of medical devices. It also positions the Mexicali facility as part of TT Electronics' global network of ISO 13485-certified and FDA-registered sites equipped for clean room manufacturing.
“Achieving ISO 13485 certification in Mexicali is a reflection of both our operational excellence and our long-term investment in serving healthcare customers at the highest level,” said Michael Leahan, Executive Vice President of Commercial at TT Electronics, in a press release. “This site was purpose-built to support our customers’ medical device journeys – from early engineering engagement to full-scale production – providing local support with global scale."
TT’s Mexicali facility provides high-mix, low to medium volume EMS capabilities, including complex PCB assembly, testing, system integration, and high-level assembly. The site supports customers in the medical, aerospace, and industrial sectors, with a strong focus on operational excellence in regulated markets.
“With an established footprint across North America, TT Electronics is uniquely positioned to help customers regionalise their manufacturing strategies without sacrificing engineering expertise or supply chain access. Our facility in Mexicali is a cornerstone of that vision – offering the flexibility, quality assurance, and engineering capability our customers count on to deliver without compromise,” Mat Freeman, Executive Vice President of North America.
