Coating Integrity and Acute Particulate Characterization
Experts from BDC Laboratories are actively involved in ASTM, AAMI, and the ISO standards committee, which develops guidance and best practices for coating integrity testing and acute particulate testing.
Our understanding of these methods enables us to validate any simulated use tracking pathway, including peripheral, neurological, coronary, and radial access pathways within our established test apparatus.
The BDC Laboratories team brings proven regulatory submission experience in evaluating many technologies, including stents, heart valves, endovascular delivery systems, occluders, guidewires, guide catheters, PTCA catheters, drug-coated balloons (DCBs), and vena cava filters.
Service Highlights
Standards-Driven Excellence
As the premier testing service provider for coating integrity and acute particulate studies, BDC Laboratories adheres to the published guidance documents listed below, as well as the AAMI TIR42 technical report for the Evaluation of Particulates Associated with Vascular Medical Devices.
Reliable, Repeatable Results
As experts in validating and executing these testing programs, trust BDC Laboratories to execute these complex studies correctly the first time.
Complete Testing Solution
Our team supports all aspects of medical device corrosion assessment, including developing the testing strategy, establishing protocols, performing data analyses, and providing regulatory quality final reports.
Relevant Standards
ASTM Standards
ASTM F2743
- Pre-Test Coating Inspection
- Post-Test Coating Inspection
- Baseline Particulate Assessment
- Simulated Use Particulate Assessment
ASTM F3320
- Balloon Drug Coating Integrity
- Simulated Use Acute Particulate Testing
FDA Guidance
- Pre-Test Coating Inspection
- Post-Test Coating Inspection
- Simulated Use Particulate Evaluation
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.