Aran Biomedical Teoranta
Aran Biomedical offers expert design, development and manufacturing solutions for implantable medical devices. Our core technology portfolio and expertise deliver solutions that reduce profile and improve device performance. We offer a full range of low-profile biomaterial coverings for implantable devices including custom development of low-profile implantable textiles, high-precision implant coating and PTFE frame encapsulation. In addition, we provide advanced micro-wire braiding of implants and catheter tip components. All of our equipment is software controlled for precision manufacturing, while we provide a suite of post processing capabilities to maximise device performance and assemble complex structures. Biomedical partners with medical device OEM’s globally, enabling companies to supply next generation products to clinicians and their patients.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About Us
The company is located in the medical device hub of Galway, Ireland. Situated on the picturesque shores of Galway bay, the company’s name is a reference to the Aran Islands, a collection of three islands situated at the entrance to Galway Bay. Aran Biomedical partners with medical device OEM’s globally, enabling companies to supply next generation products to clinicians and their patients. By leveraging our extensive biomaterials expertise and quality assured processing capabilities, Aran Biomedical converts concepts into cutting edge implantable solutions. These are supplied as stand-alone components, integrated into implantable structures, or as finished packaged devices.
Facilities
- High tolerance micro-processing of biocompatible materials
- Medical textile knitting, weaving and braiding (GMP environment)
- Narrow fabric weaving and warp knitting
- Medical device coating applications
- Implant encapsulation processing
- Biomaterial moulding and casting
- R&D and materials laboratory
- Lean manufacturing cells for volume manufacturing
Quality Commitment and Certifications
Aran Biomedical’s Quality Management System is certified to EN ISO 13485:2016 for both manufacturing and the provision of design services. We are also compliant to FDA standards; 21 CFR 820 Quality System Regulation Medical Devices Good Manufacturing Practice
Our quality orientated systems and services ensure that products are manufactured to the highest standards while maintaining:
- Identification and traceability from concept design and development of prototypes right through to commercial manufacturing,
- Focus on risk management activities and design control activities during product development,
- Controls in the work environment to ensure product safety,
- Environmental and microbiological controls,
- Specific requirements for documentation, validation of processes and test method preparation for sterile medical devices and
- Biomaterials testing according to ASTM and ISO standards.
Good Manufacturing Practice (GMP) is integrated into every process, protocol and test method carried out by our team. Our ISO Class 8 / Class 100,000 cleanroom space ensures that every unit designed and manufactured meets the necessary criteria.
End-to-End Product Development Services
Located in the medical device hub of Galway, Ireland, Aran Biomedical is a trusted partner in design, development and manufacture of implantable medical devices. We provide expertise in low profile custom medical fabrics and advanced metal & polymer braiding, as well as high precision biomaterial covering and coating of implants. Aran Biomedical also has in-depth knowhow in the forming and processing of absorbable materials. Our solutions can be provided as components, integrated into delivery systems or as finished packaged devices. We have a proven track record in innovative design and quality-assured manufacturing to ISO13485 standards, delivering solutions for a range of different markets and medical applications. Aran Biomedical enables you to supply next generation products to clinicians and their patients.