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Robert Nami

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United States

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1 to 5 of 11 total
Posted By Robert Nami 10-May-2018 06:47
Found In Egroup: Regulatory Open Forum
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thank you very much for the helpful response. ------------------------------ Robert Nami Carlsbad CA United States ------------------------------
Posted By Robert Nami 09-May-2018 15:10
Found In Egroup: Regulatory Open Forum
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I need to validate an optical inspection machine/system that is used to measure features of screws.  These are screws that are used in conjunction with a class 2 medical device. System is made by Oasis Inspection Systems.  It is basically a shadowgraph with easy semi automaed edge detection and measurement ...
Posted By Robert Nami 28-Nov-2017 11:48
Found In Egroup: Regulatory Open Forum
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Thanks for your response Ginger. The problem we have is exactly what you said:  "identify the status at any given site at any given time". If you have a GoTo reference that you'd recommend off top of your head, please share title. The couple books I briefly reviewed really didn't have a solution. ...
Posted By Robert Nami 16-Nov-2017 16:33
Found In Egroup: Regulatory Open Forum
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In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system. The DME gets ...
Posted By Robert Nami 14-Nov-2017 11:29
Found In Egroup: Regulatory Open Forum
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In a scenario that I am involved with, a DME (data medium exchange) file is used in conjunction with another software to allow customers to design a regulated class II part. We treat the DME file as a controlled document.  It is stored in a document and change control software system. The DME gets ...