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We need to write a ISO 11135 part 1 and part 2 compliant Validation Protocol. I have one to use as a template and I have details of the new Class III medical device to fit into the existing protocol. The Medical Device has a predicate validation but the manufacturer has lost it for timing reason and wants to move the validation to a new sterilization provider in another part of the USA. All in All I need this turned around very quickly so if you are interested in writing , copywork, and checking for technical soundness, this could be a job for you. I would like to have the protocol written by End of business, Thursday May 18th MST. I have lots of data on the device, the ISO standards, the old PCD work that has been done by the manufacturer, etc. You must have experience in technical writing and regulatory affairs mostly with medical device sterilization work. We work all the time so out of country applicants are welcome.
Added 23 MAY 2012,...
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