Galway Biomedical
Contract manufacturer and ODM for biomaterial-based implantable medical devices. Offers end-to-end services from concept feasibility and rapid prototyping through process development, validation, and scalable volume manufacturing under an ISO 13485 quality management system. Operates a temperature- and humidity-controlled cleanroom facility and specialises in complex low-profile braiding, biomaterial processing, and advanced implant coatings.
Industries
Nr. of Employees
small (1-50)
Services
Concept feasibility & rapid prototyping
Functional prototyping based on client design inputs to assess feasibility and iterate early concepts.
Process development and optimisation
Definition and locking of manufacturing processes, specification of equipment and materials, and development of repeatable production methods.
Process validation and quality testing
Creation and execution of testing plans, validation of processes and product quality testing prior to manufacturing transfer.
Scale-up and volume manufacturing
Material sourcing, supplier qualification, equipment acquisition/installation, manufacturing transfer, and volume production in cleanroom environments.
Advanced coating services
In-house dip-coating, hydrophilic lubricious coatings and elastomeric coatings for nitinol and polymer braided devices, including multi-layer systems and thin-film membranes.
Packaging and cleanroom assembly
Packaging, labelling and traceability workflows performed in ISO Class 8 cleanroom areas, configurable to client requirements.
Concept feasibility & rapid prototyping
Functional prototyping based on client design inputs to assess feasibility and iterate early concepts.
Process development and optimisation
Definition and locking of manufacturing processes, specification of equipment and materials, and development of repeatable production methods.
Process validation and quality testing
Creation and execution of testing plans, validation of processes and product quality testing prior to manufacturing transfer.
Scale-up and volume manufacturing
Material sourcing, supplier qualification, equipment acquisition/installation, manufacturing transfer, and volume production in cleanroom environments.
Advanced coating services
In-house dip-coating, hydrophilic lubricious coatings and elastomeric coatings for nitinol and polymer braided devices, including multi-layer systems and thin-film membranes.
Packaging and cleanroom assembly
Packaging, labelling and traceability workflows performed in ISO Class 8 cleanroom areas, configurable to client requirements.
Expertise Areas
- Braided implantable device manufacturing
- Biomaterials processing (metal, non-resorbable and resorbable polymers)
- Implantable device coating development
- Process development and validation
Key Technologies
- Automated braiding (3–96 carriers)
- Reel-to-reel and over-mandrel braiding
- Dip coating
- Hydrophilic lubricious coatings