Method and Apparatus for Medical Devices Under Regulatory Control

摘要

Systems, devices, methods, and program products are provided for operating a medical system that is operable within at least two different medical device regulatory classes. A device control module receives an indicator for performing at least one procedure with a medical device. Based on the indicator, it selects a binary image for booting the control module from among multiple images including a controlled-type and a non-controlled type, which operate in different regulatory classes. A controlled-type image, which may be FDA PMA or other regulatory classes, is verified to be unaltered, and is then used to operate as a regulated medical device. The indicator can be automatic or manual. The indicator may result from connection of a specific medical device or peripheral device or may be user input.