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TT Electronics Achieves ISO 13485 Medical Certification at Mexicali EMS Facility
June 27, 2025 | TT ElectronicsEstimated reading time: 1 minute
We are pleased to confirm that our state-of-the-art electronics manufacturing services (EMS) facility in Mexicali, Mexico, has achieved certification to ISO 13485:2016. This milestone underscores TT Electronics’ commitment to delivering high-quality, compliant, and reliable manufacturing solutions to its global customers in healthcare and life sciences.
ISO 13485:2016 is an internationally recognised quality management standard for the manufacture of medical devices. It includes specific requirements that help organisations ensure their medical devices meet both customer and regulatory demands for safety and efficacy. Mexicali now joins TT’s global network of ISO 13485-certified and FDA-registered sites with clean room manufacturing capabilities, further strengthening the company’s ability to support complex, regulated programs worldwide.
“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. “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. As customers prioritise supply chain resilience and speed to market, we’re proud to offer them an agile, nearshore solution that doesn’t compromise on quality or capability.
Mat Freeman, Executive Vice President of North America, said: “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.”
TT Electronics’ Mexicali facility provides high-mix, low to medium volume contract manufacturing capabilities, including complex PCB assembly, testing solutions, system integration, and high-level assembly. With a strong focus on operational excellence for regulated markets, the site supports a diverse portfolio of customers across the medical, aerospace, and industrial sectors.
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