BDC Laboratories principals actively participate in the ISO Cardiac Valve Prosthesis Committee (WG1) responsible for the ISO 5840 heart valve standard and ISO 5910 heart valve repair device standard. Leveraging on our intimate knowledge of cardiovascular fluid dynamics, heart valve testing requirements and regulatory landscape, our team can provide a unique resource for hydrodynamic performance testing, accelerated durability testing and dynamic failure mode (DFM) testing for both heart valve prostheses and cardiac valve repair devices. Moreover, as experts in testing of endovascular stents, the BDC team can execute heart valve frame fatigue and structural assessment requirements of transcatheter heart valves.
Our heart valve prosthesis testing and cardiac valve repair device testing capabilities, per the published guidance documents are listed below. In addition to these outlined tests, BDC is capable of supporting all aspects of the device evaluation, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. Finally, all test programs can be executed at a level consistent with the data’s application to optimize efficiency in time and cost, ranging from abbreviated early stage development studies to final, formal regulatory submission studies.