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Episode description
In this episode, we turn to one of the most regulated and quality-driven industries in global manufacturing: medical devices. Our guest, Bernardo Gómez, Plant Manager at GC Dental in Silao, Guanajuato, shares how this multinational company — of Japanese origin, with commercial operations in the U.S. and headquarters in Switzerland — chose Mexico as its strategic gateway to the Americas.
Bernardo explains how GC Dental's facility in Silao has become the main entry point for products manufactured in Japan and distributed throughout Mexico and the United States, taking advantage of Guanajuato's proximity to Manzanillo port, the Laredo border crossing, and key distribution centers.
The conversation also dives into one of the biggest challenges for medical device companies in Mexico: navigating the regulatory environment, including COFEPRIS compliance, product registrations, and import/export requirements — and how having the right local partner makes all the difference.
Finally, Bernardo shares his perspective on why Mexico is a smart move for medical devices: the trade benefits, operating costs, labor availability, and the ability to stay focused on quality and production while American Industries manages the administrative, compliance, and HR side.
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