biomedical textiles, specializing in braided and
nonwoven components for medical devices.
One of the quality control functions of the biomedical textile manufacturing process is to verify certificates of testing from suppliers of critical raw materials, or perform actual testing, to ensure biomedical textiles meet customer specifications and performance criteria.
In the race to help our customers develop new products as quickly as possible, US BioDesign has invested heavily in equipment and capabilities to conduct critical in-process testing before, during and after product manufacturing. At US BioDesign, we conduct material testing using validated, industry-standard ASTM test methods. Additionally, we have a network of qualified partner companies for specialized testing when we need to outsource.
Types of Material Testing
Depending on the material and medical device, there is a variety of testing that US BioDesign provides. Biomedical material testing requires specialized equipment, validated test methods and adherence to established test standards to ensure effective quality control and that we always meet our customer’s specifications.
Our on-site physical property testing capabilities include:
- ASTM D1777 Thickness of textile materials
- ASTM D3822 Tensile properties of fibers
- USP Suture diameter and tensile testing
- Fabric construction analysis (Braided, knitted, woven)
- Pore size measurement
- Water Permeability
- Digital photo-microscopy
- DSC testing for active Af
Our off-site testing
Biocompatibility TestingThis is a series of tests, typically performed by qualified third-party laboratories to screen and evaluate the safety and efficacy of raw materials or manufactured components intended for use in implantable medical devices. Medical device companies have the ultimate responsibility to ensure the final device meets ISO 10999 biocompatibility requirements.
In-House Material Testing for Biomedical Textiles
We work directly with our customers’ engineering teams to develop custom products and processes to manufacture their biomedical textiles. Our customers can choose how involved they want to be in overseeing test protocols and working directly with our Quality and Engineering staff.
Contact US BioDesign to Learn More about our Biomedical Material Testing
We are dedicated to providing the highest quality biomedical textiles for your needs. You can count on our knowledge and experience with biomedical textile manufacturing, and to deliver products that meet your specifications.