TL;DR: Cork-based Alps Electric EMS has achieved ISO 13485 certification, a significant milestone in its expansion into the medical technology sector. This certification underscores the company’s commitment to quality and positions it as a trusted partner for medical device manufacturers.
Cork manufacturing firm Alps Electric EMS is taking bold strides into the medical technology sector with its recent achievement of ISO 13485 certification. Recognized internationally, this standard highlights a company’s dedication to quality management systems in the medical device industry. Headquartered in Japan, Alps Electric has been a fixture in Millstreet, North Cork, since 1988, primarily known for producing electronic parts for the automotive industry. With 350 employees in its Cork facility, the company is shifting its focus to electronics manufacturing services (EMS) beyond automotives.
John Foley, managing director of Alps Electric EMS, described the move into medical technology as a “natural progression” for the company. He noted, “The disciplines, quality systems and attention to detail required by the medical sector closely align with the standards we have been applying throughout our operations for many years.” The speed with which the company achieved this certification, finishing the process in what some thought could take over a year, can be attributed to the teamwork and determination of the staff. “Everybody understood the importance of what we were trying to achieve,” Foley added, highlighting the collective effort that went into this accomplishment.
With strong capabilities across engineering, automation development, injection moulding, electronics manufacturing, and supply chain expertise, Alps Electric EMS is well-equipped for this new venture. Senior quality manager Thomas O’Leary mentioned that the ISO 13485 certification is a key differentiator, providing medical device manufacturers with the confidence they seek in a reliable manufacturing partner.
Now, if we’re honest, it’s refreshing to witness a local company not just sitting back and resting on its laurels. In the ever-competitive world of manufacturing, particularly in tech, it’s easy to be left behind. The medical sector’s stringent requirements might seem daunting, but Alps Electric’s proactive approach in embracing this challenge reflects a willingness to innovate and adapt. It doesn’t hurt that the company gets to showcase its ISO 13485-certified capabilities at the Medical Technology Ireland event at Galway Racecourse later this month.
Who knows, perhaps this new focus will inspire others in the region to step up their game? It’s about time we show the world that Irish ingenuity isn’t limited to artisan cheeses and stout—it extends to cutting-edge medical technologies as well. Of course, let’s hope they remember to bring a few samples of that cheese for good measure.
As a point of interest, did you know that the global medical device market is expected to reach over €500 billion by 2028? With advancements in technology and increasing demand, companies like Alps Electric EMS are looking at a fertile landscape for growth. This is indeed a time of opportunity in the medical technology sector—a fact not lost on the folks in Millstreet.
