Capabilities:

• Endovascular Graft Testing
• Stent Testing
• Catheter Testing
• Heart Valve Testing
• Venous Valve Testing
• Durability, Life-Cycle Testing
• Simulated Cardiovascular Networks
• Nerve Stimulation Lead Testing
• Fabric Porosity Testing
• General Mechanical Testing
• Material and Biomaterial Characterization
• Polymer Testing (GPC, IR, and DSC)

Key Benefits of BDC Labs:

• Extensive experience in FDA and regulatory submissions
• Rapid turnaround times on all activities
• Active in testing standards development
• Established and audited GLP testing capability
• Independent third party testing and evaluation
• Extensive product development experience
• Complete confidentiality

Medical Device Testing Overview

The BDC Laboratories team has over 35 years experience in medical device product research, development, and testing. Our focus is on functional, engineering based, testing of medical devices including Class 2 and Class 3 devices. The BDC team actively participates in The American Association of Medical Instrumentation (AAMI), the International Standards Organization (ISO) and ASTM Endovascular Device and Stent Standards Committees. As participants on these committees, BDC personnel have a unique understanding of developing medical device testing and verification plans, along with protocols to support FDA submissions on many types of medical devices.

Stent / Stent Graft Testing

Comprehensive stent and stent graft testing programs are available based on ISO 25539, including durability, and the FDA’s Guidance Document 1545.

Vascular Graft Testing

Comprehensive vascular graft and A/V access graft testing programs are available based on ISO 7198 in its entirety.

Catheter Testing

BDC Labs offers comprehensive testing programs based on ISO 10555 and ISO 11070 in their entity, as well as the FDA Guidance Document 824. In addition, BDC offers dialysis catheter testing, including recirculation quantification.

Heart Valve Testing

Heart valve durability and hydrodynamic testing activities are available based on the ISO 5840 guidance document.

General Testing Services

With our extensive experience in functional evaluation of medical devices, BDC Laboratories excels in testing on all types of devices and technologies. Our team can create custom test programs, fixtures, and equipment for any technology.