• Medical Device Testing
  • Stent / Stent Graft Testing
  • Catheter Testing
  • Additional Testing Services
  • Device Testing Experience
• Cardiovascular Flow Systems
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Device Testing

The BDC 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 Labs team actively participates in The American Association of Medical Instrumentation (AAMI), the International Standars 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 and protocols to support FDA submissions on many types of medical devices.

Some capabilities of BDC Labs include:

• 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
• Explant Analysis
• Material and Biomaterial Characterization
• SEM
• Polymer Testing (GPC, IR, and DSC)

Key benefits of using BDC Labs are:

• Extensive experience in FDA and regulatory submissions
• Rapid turn around times on testing activities
• Personnel active in testing standards development
• Independent third party testing & evaluation
• Personnel with extensive product development experience
• Validated and audited GLP testing capability
• In-Vitro and In-Vivo Testing Capability
• Complete confidentiality