Coating Integrity and Acute Particulate Testing

As active members of the ASTM and ISO standards committee, the BDC Laboratories’ team participates first-hand in outlining the guidance and expectations for both coating integrity testing and acute particulate testing. Our understanding of these methods goes beyond simply testing practices to allow us the ability validate the use of any simulated use test model, including: peripheral, neurological, coronary and radial access pathways within our established test apparatus. The BDC Labs team has proven experience for regulatory submissions evaluating many technologies including: Stents (ASTM 2743), Transcatheter Heart Valves, Endovascular Delivery Systems, Guidewires, Guide Catheters, PTCA Catheters (FDA Guidance Document) and Vena Cava Filters.

BDC Labs coating integrity and acute particulate testing programs meet the published guidance documents listed below. As experts in validating and executing these testing programs, entrust BDC to ensure these complex studies are executed correctly the first-time.

Testing Services

  • Pre-Test Coating Inspection
  • Post-Test Coating Inspection
  • Baseline Particulate Assessment
  • Simulated Uses Particulate Assessment
  • Pre-Test Coating Inspection
  • Post-Test Coating Inspection
  • Simulated Uses Particulate Evaluation
ISO 17025 Accreditation

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Medical Device Testing

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. Read more »

Vascular Graft Testing

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

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. Read more »

Heart Valve Testing

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

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. Read more »