ABSTRACT
Overview .................................................................................................... 217 In Vitro Testing .......................................................................................... 218
The Animal Models ............................................................................... 218 The Project............................................................................................. 219
The In Vivo Study...................................................................................... 219 Data Collection ...................................................................................... 220 The Team............................................................................................... 220 Good Laboratory Practices ................................................................... 220
Summary..................................................................................................... 221
Medical devices must be tested in a living system (in vivo testing) in order for them to be approved by the Food and Drug Administration (FDA) for clinical trials. This can be a daunting task to some. In order to minimize the fear and trepidation that comes with this aspect of device development, I will lay out a guide that will allow the reader to map out a schedule for success and minimize chances for failure.