Method and apparatus for electronically managing, manufacturing, and testing of a medical device in accordance with a set of regulatory provisions

A system for manufacturing/testing a device in accordance with a set of regulatory provisions, the system comprising:

• at least one assembly station and at least one testing station;
• at least one user station positioned proximate to the at least one assembly and the at least one testing station, the at least one user station having a monitor configured to display at least a GUI;
• and
• a main station remote from the at least one assembly station and the at least one testing station, the centralized facility networked with the at least one user station, and having a processor configured to:
• display a GUI on each user station monitor;
• populate the GUI with a number of markers identifying a status of a series of tasks associated with at least one of manufacturing and testing a device;
• detect a user input identifying completion of a task associated with at least one of manufacturing and testing of the device;
• authenticate the user based on a set of regulatory provisions;
• and if the user is authenticated
• update the number of markers to reflect on the GUI completion of the task.

A computer data signal embodied in a carrier wave and representing a sequence of instructions that when executed by a processor causes the processor to:

• display a number of markers, each marker indicating a status of a task associated with at least one of manufacturing and testing a device;
• display a master device history record for the device;
• and
• update a marker and the device history record upon completion of a task only if data indicating completion of the task is certified in accordance with a set of regulatory provisions.