Test Systems
BDC’s testing equipment has been conceived, designed, and manufactured from the ground-up, based upon an academic research foundation, and then coupled to an industry R&D philosophy. This paradigm shift in medical device test equipment has facilitated a new generation of test systems that allows for ultimate adaptability and comprehensive test sample monitoring.
BDC test equipment supports functional and mechanical product evaluation for regulatory submission of both Class 2 and Class 3 medical devices for vascular grafts, endovascular stents, catheters, and heart valve technologies. BDC can also help design, construct, and validate test equipment for unique testing requirements.
Testing Equipment Overview
BDC’s testing equipment utilize our validated proprietary Statys™ closed-loop control and monitoring software. The Statys™ control and data acquisition platform allows for real-time continual data monitoring and data acquisition of the device parameters of interest throughout the test period. This unique software allows for user programmable parameters and controls for each test station and control of the system alarms for comprehensive test sample monitoring and analysis of the device testing.
BDC’s Stent testing equipment and Heart Valve durability and fatigue equipment have been designed with our proprietary RB-5™ Drive System. In the VDT-3100 Heart Valve durability system this unique drive system allows for comprehensive control of the loading profile, thus minimizing excessive pressure spikes during valve closure, creating an accelerated test environment that more closely mimics clinical performance. Our pulsatile radial durability testers incorporate the RB-5 Drive System, coupled with our Innovative Dual-Drive Emulator to produce balanced pressures at either end of the test sample simultaneously, eliminating the need for two drivers.
All of BDC’s medical device test equipment is offered in a standard platform which may be customized for each client’s specific needs to incorporate customizable driving waveforms, data analysis algorithms, unique test sample fixtures, and customized software monitoring or hardware requirements.