Cardiac Occluder Testing
With years of experience in cardiac occluder evaluation, experts from BDC Laboratories are actively involved in the ISO committee (WG8) responsible for drafting the standard for cardiac occluders. BDC Laboratories conducts acute bench testing, like particulate generation and radial force testing, and durability testing for implants and their coverings.
As experts in stent and stent graft evaluation, BDC Laboratories executes the frame fatigue and structural assessments required for cardiac occlude technologies too.
Service Highlights
Standards-Driven Excellence
BDC Laboratories’ cardiac occluder implant testing capabilities, per the published guidance documents, appear below.
Complete Testing Solution
Our team supports all aspects of device 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
22679
- Fatigue Testing
- Durability Testing
- Component Corrosion Assessment
- Visual Inspection
- Dimensional Verification
- Device MRI Compatibility
- Simulated Use Assessment
- Acute Particulate Characterization
- Radial Force Testing
- Delivery System Assessments
ASTM Standards
- F2052: Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
- F2119: Evaluation of MR Image Artifacts from Passive Implants
- F2129: Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
- F2182: Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (MRI)
- F2213: Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
- F2477: In vitro Pulsatile Durability Testing of Vascular Stents
- F2503: Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
- F2942: In vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
- F3044: Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
- F3067: Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
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
RDT-7600i | Pulsatile Durability System
LDT-1800 | Uniaxial Fatigue System
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.