Method and apparatus for electronically managing, manufacturing, and testing of a medical device in accordance with a set of regulatory provisions
First Claim
1. A method of coordinating the manufacture and testing of a device, the method comprising the steps of:
- determining a series of tasks for at least one of manufacturing and testing a device;
developing a master device history record integrating the series of tasks and the master device history record into a GUI and accessible by one or more persons responsible for the at least one of manufacturing and testing of the device; and
automatically updating a particular task and the master device history record based on an authorized input to the GUI.
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Accused Products
Abstract
The present invention is directed to a method and apparatus of managing and maintaining data associated with the manufacturing and/or testing of a device. Specifically, the present invention provides a GUI that displays digitized work instructions for service technicians and engineers associated with the manufacturing and/or testing of the device. Moreover, the present invention includes a platform whereby historical data associated with the manufacturing and testing of a device is digitally maintained and automatically collected upon the testing of a device. By incorporating authenticated input associated with changes in the manufacturing and/or testing process as well as data associated with the actual manufacturing and/or testing of the data, the present invention manages the manufacturing and/or testing of a device in accordance with strict regulatory concerns.
12 Citations
21 Claims
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1. A method of coordinating the manufacture and testing of a device, the method comprising the steps of:
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determining a series of tasks for at least one of manufacturing and testing a device;
developing a master device history record integrating the series of tasks and the master device history record into a GUI and accessible by one or more persons responsible for the at least one of manufacturing and testing of the device; and
automatically updating a particular task and the master device history record based on an authorized input to the GUI. - View Dependent Claims (4, 5, 6, 7, 8)
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- 2. The method of claim 2 further comprising the step of automatically updating only if the input complies with a set of regulatory provisions.
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9. A system for manufacturing/testing a device in accordance with a set of regulatory provisions, the system comprising:
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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 authenticatedupdate the number of markers to reflect on the GUI completion of the task. - View Dependent Claims (10, 11, 12, 13, 14, 15)
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16. 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:
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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. - View Dependent Claims (17, 18, 19, 20, 21)
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Specification