Precision Manufacturing. Scalable Solutions
Your Commercialization Partner.
Manufacturing
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Our Manufacturing Services
PBC Biomed supports the design, development, manufacture and validation of medical devices, biologics and combination products. By leveraging specialist knowledge and technical capabilities, our team enables innovators to scale their products from prototype to market-ready devices while maintaining compliance, quality, and cost efficiency. These services bridge the gap between design, development, and full-scale production, ensuring that devices can be reliably manufactured to meet global standards.
- Design
- Development
- Validation
Technology Transfer
The PBC Biomed headquarters in Shannon, Ireland, is an ISO 13485-certified facility equipped with cleanrooms and laboratories. We provide GMP-compliant manufacturing leveraging our extensive experience and proven procedures. Alongside our engineers and scientists, a dedicated program management team supports technology transfer projects, ensuring that timelines and milestones are achieved.
Contract Manufacturing
We have strong expertise and a broad range of capabilities across multiple areas of manufacturing, including lyophilisation, implant coating, additive manufacturing and 3D printing. Our ISO 13485-certified facility and ISO 9001-certified processes enable us to perform cleanroom manufacturing, as well as manage the packaging and sterilisation of a wide range of medical device products.
Distribution
At PBC Biomed, we understand how critical it is for patients worldwide to access latest medical technologies. We provide specialised distribution services, ensuring products reach healthcare providers and patients safely, efficiently, and in compliance with global regulations. These services cover everything from supply chain planning and storage to packaging, shipping, and logistics management, helping clients expand their reach into new markets.
Quality Management
Our team of experts provide comprehensive QMS support across the full spectrum of requirements. We offer programs covering documentation implementation and management, internal auditing, design control, design risk management, supplier auditing, process validation, training, and external audit support. In addition, we conduct gap assessments against key international standards, including ISO 13485:2016, ISO 9001:2015, and FDA 21 CFR Part 820.
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