BDC Laboratories’ personnel are active members of the AAMI/ISO 25539 Standard Workgroup (WG3), which is responsible for the development of ISO 25539-3 for Vena Cava filter testing and evaluation. From this first-hand experience in the drafting of the evaluation expectations, BDC offers comprehensive vena cava filter and intravascular filter testing programs. In addition to the tests outlined below for our capabilities, the BDC team excels in developing custom test methods specific to novel and unique filter technologies.
Based on our extensive knowledge of testing and evaluating vena cava filter technology, BDC can offer a complete testing solutions as presented below. Our group is capable of supporting all aspects of the evaluation, including developing the testing strategy, establishing protocols, validating methods, performing data analyses and providing regulatory quality final reports. Moreover, 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.