Alps Electric EMS has achieved ISO 13485 certification at its Millstreet, Co Cork facility, a quality management standard that gives the electronics manufacturer a formal route into medical device production and positions it as a credible manufacturing partner for medtech companies evaluating new suppliers.

Alps Electric EMS has capabilities spanning engineering, automation development, injection moulding, electronics manufacturing, testing, assembly and supply chain management, and the company said the certification marks an important milestone in its growth as a trusted, high-reliability manufacturing partner for medical devices.

Managing director John Foley said medical technology represents a natural progression for the Millstreet business, since the quality systems and attention to detail required by the medical sector closely align with standards the company has applied across its operations for many years. He said the achievement reflected the team's effort in delivering the certification faster than the year or more it was told the process could take.

Senior quality manager Thomas O'Leary said the certification will give medical device companies assured confidence when choosing a manufacturing partner, and the company plans to showcase its ISO 13485-certified capabilities at the Medical Technology Ireland event at Galway Racecourse from 23 to 24 September.

Alps Electric EMS is headquartered in Japan and has had a presence in Millstreet since 1988, originally manufacturing electronic parts for the global automotive industry; the company employs 350 people at the Cork facility and has more recently expanded its electronics manufacturing services beyond automotive into sectors including medtech.

The certification reflects a wider pattern of automotive electronics manufacturers diversifying into medtech, a higher-margin, quality-driven sector less exposed to the cyclicality of automotive supply chains.

The timing tracks strong growth in the category, with the electronics manufacturing services market for healthcare and medical devices forecast to expand from $76.5bn in 2026 to $142.8bn by 2036, according to Fact.MR.

For the sector, ISO 13485 certification lowers the barrier for automotive-heritage electronics manufacturers to win medtech contracts, broadening the pool of Irish manufacturers competing for device manufacturing work beyond established medtech specialists.

The wider signal for the sector is that quality certification, rather than fresh capital investment, is becoming the entry ticket for diversified manufacturers seeking to access adjacent, higher-value sectors such as medtech.

Source: Irish Examiner / Fact.MR