Guidewire, Introducer & Dilator Testing
BDC Laboratories offers comprehensive guidewire, introducer, and dilator testing solutions based on the ISO 11070 standard and FDA guidance documents. Guidewires, introducers, and dilators function as accessories that aid in the advancement and placement of intravascular devices. The associated mechanical performance tests qualify their safety and ensure they meet requirements.
As an expert in testing and evaluating many intravascular devices, BDC Laboratories understands how to evaluate these accessories and interpret the ISO and FDA guidance documents.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ guidewire, introducer, and dilator evaluation capabilities, per the published guidance documents, appear below.
Complete Testing Solution
Our team supports all aspects of evaluation, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Scalable Test Program
We execute all test programs according to the data’s application, ranging from abbreviated early-stage development studies to final, formal regulatory submission studies.
Relevant Standards
ISO Standards
11070
- Surface Inspection
- Corrosion Resistance
- Needle Point
- Strength of Union of Needle to Hub
- Freedom from Leakage from Sheath Introducer
- Freedom from Leakage Through Hemostasis Valve
- Peak Tensile Force
- Guidewire Fracture Test
- Guidewire Flexing Test
- Peak Tensile Force of Guidewire
- Strength of Union Hub to Dilator
FDA Guidance
Coronary, Peripheral, & Neurovascular Guidewires
- Dimensional Verification
- Visual Inspection
- Simulated Use
- Tensile Strength
- Tip Pull
- Torque Strength
- Torqueability
- Coating Integrity
- Particulate Evaluation
- Coating Lubricity
- Corrosion Resistance
- Kink Resistance
- Tip Flexibility
Testing Backed by ISO/IEC 17025 Accreditation
At BDC Laboratories, quality is central to everything we do. We maintain ISO/IEC 17025:2017 accreditation and comply with relevant portions of 21 CFR Part 58 (Good Laboratory Practices), among other U.S. and international governing standards. With a comprehensive quality management system, we ensure service and product integrity with a focus on regulatory compliance and continuous improvement.
Why BDC?
Built Around Your Goals
From first conversation to final report, we collaborate with your team to design and execute accredited testing programs aligned with your device goals and regulatory requirements.
Regulatory-Ready, On Time
With ISO/IEC 17025:2017 accreditation and 40+ years of industry experience, we deliver precise, regulatory-ready results on timelines that keep your project moving.
Reliable, Responsive Partnership
You’ll work with project managers who stay engaged throughout the process. They’re available for questions, quick to respond, and focused on keeping your program on track.
Explore More
Testing Services
Testing Equipment
Silicone Solutions
Simulation Solutions
Connect with an Expert at BDC
Provide a few details about your project, and a BDC Laboratories team member will respond within 2 business days to advise on next steps.