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Subject:Documentation Systems From:"Brian L. Graham" <blgraham -at- IGS -dot- NET> Date:Wed, 1 Oct 1997 06:35:26 -0400
I have been hired by a small company to put together an FDA submission for
approval to market a medical device. I have also been asked to prepare a
submission for ISO 9000 registration. In addition to learning how to find
my way through the red tape in both organizations, much of my work will
involve making sure that all of the documentation for the device is
satisfactory and that mechanisms are in place to show that the company
conforms to the standards for good manufacturing practices.
By the way, I am working in Ottawa, Canada.
Does anyone know of a source(s) of information on how to set up a document
control system to meet the above requirements?