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.