Biomerics Announces  ISO 13485 Cleanroom Expansion in Ireland


Biomerics High-Performance Balloon Design & Development Capabilities Expansion in Galway Demands New ISO 13485 Cleanroom Facility

Biomerics, the leading vertically integrated medical device contract manufacturer serving the interventional device market, has today announced the opening of a 2,000 sq. ft. Balloons & Balloon Catheters Centre of Excellence in Galway and the creation of approximately 40 jobs over the next five years. This is Biomerics’ first facility in Europe and the second facility outside the United States after Costa Rica. It will become home to a growing team dedicated to the development and manufacturing of balloons and balloon catheters and act as an extension to the operations in Athens, TX.

Galway-based Minister of State in the Department of Transport Hildegarde Naughton welcomed the announcement stating, “I am delighted to welcome Biomerics to Ireland and indeed to Galway where it has chosen to establish its Balloons & Balloon Catheters Centre of Excellence. This move brings with it the creation of 40 jobs providing new opportunities for people to work and live in Galway, which has a proven track record when it comes to providing a rich pool of talent with a highly skilled and educated workforce. Today’s announcement is a great achievement for the West of Ireland and signals a bright future for businesses across the country.”

Jhovanny Ortega, Commercial Director, Interventional Balloons,will lead the new balloons & balloon catheters research and development facility. It will be a dedicated space for designing and developing complex balloon components used in future medical devices and applications, using various materials including polyurethanes, nylons, PET, and more. “I look forward to leading a group of individuals and creating cohesive teams that ultimately support the Biomerics vision,” says Jhovanny.

The new office will be located at 2 Liosban Business Park in Galway. Biomerics chose to locate in Galway due to the region’s significant cluster of medical device companies, a skilled labor pool, an international reputation, and access to suppliers and vendors. The office will be equipped with multiple balloon-forming machines, state-of-the-art test equipment, and a cleanroom that is ISO 13485:2016 certified.

“Having this new location is another step in our strategic growth plan. We continue to see a strong need around balloon component development,” says Todd McFarland, President of Biomerics FMI. “Our focus will be on next-generation technologies, including micro- and sensing balloons. Additionally, the facility will provide more capacity to support our strategic customers in the interventional markets we serve.”

Global Head of Life Sciences at IDA Ireland Michael Lohan said: “Biomerics’ decision to locate its first European site in Galway is terrific news for Ireland and reflects the established Lifesciences cluster in the West Region. This announcement is an exemplar of IDA Ireland’s continued commitment to winning innovative investments and job creation in regional locations. I wish Biomerics every success with this investment.”

About Biomerics

About Biomerics

Founded in 1994, Biomerics is the leading vertically integrated medical device contract manufacturer serving the interventional device market. Trusted as a partner with extensive engineering expertise and solutions, Biomerics supplies 20 of the top 30 medical device OEMs. Biomerics provides engineering design and development services, technical transfer manufacturing services, and contract manufacturing services – including sterilization and packaging – for medical devices components, subassemblies, and finished medical devices through eight locations in the United States, Ireland, and Costa Rica – to meet immediate and long-term strategic needs. With our engineering Centers of Excellence, Biomerics is a leader in materials & compounding, injection molding, complex extrusion, micromachining of metals & polymers, laser processing, balloons & balloon catheters, advanced catheters & steerables, image guided intervention, and finished device assembly. In addition to operating under a certified ISO 13485:2016 quality system, Biomerics is both FDA registered and compliant with FDA 81 CFR Part 820.

SOURCE: Biomerics