About Galway Biomedical

Our Company

Galway Biomedical is an ISO 13485 certified medical device contract manufacturing company, offering medical device innovators rapid and reliable Contract Development and Manufacturing Organisation (CDMO) services for biomaterial based implantable devices. Inspired by the need to create next generation functional devices at the lowest profile possible, Galway Biomedical leverages the experience of its diverse engineering team to develop materials, equipment and processes to achieve that goal.

Regulatory Compliance

Quality and regulatory compliance are central to Galway Biomedical’s operations. Our products and services are developed and manufactured under a fully certified Quality Management system that meets the rigorous requirements of ISO13485:2016 and follows the principles of ISO14971:2019 for comprehensive risk management throughout the product lifecycle.

Our operations comply with the U.S. FDA Quality System Regulation (21 CFR Part 820) and remain aligned with the new Quality Management System Regulation (QMSR), FDA registration requirements (21 CFR Part 807), and other internationally recognised frameworks.

As a Medical Device Contract Manufacturer, we maintain an unwavering commitment to excellence. This approach has established Galway Biomedical as a trusted manufacturing partner for leading medical device companies serving the U.S. and global markets.

ISO 13485 Certificate

Our Facility

Based in the heart of Ireland's medical device hub, Galway Biomedical works with medical device innovators and end product owners to bring their products to life under an ISO 13485 certified Quality Management System. Our state-of-the-art 13,000 sqft facility, including a state of the art 13,000 sqft facility with a 4,000 sqft ISO Class 7/8 temperature and humidity-controlled cleanroom, supports medical device development, contract manufacturing, and scalable production.

Our Team

The Galway Biomedical team is a multidisciplinary group focused on advancing healthcare through materials IP creation and technology development. Comprising engineers, quality/regulatory, and operations experts, the team collaborates on cutting-edge client projects ranging from concept prototyping to volume manufacturing. Strongly connected with industry partners, the Galway Biomedical team plays a key role in translating material and technology discoveries into real-world medical device solutions.