Coating Integrity and Acute Particulate TestingAs 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.
Request InformationRequest a QuoteDownload Brochure