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FDA regulated industry: medical devices


One category you don’t have in your pull-down is medical devices, regulated by FDA. We need a PLM system that provides Quality Management System elements per 21CFR820 as well as EN ISO 13485 and includes a validation package (IQ, OQ, PQ protocol) per FDA requirements. We’re a startup on a shoestring budget, but know we’re going to grow fast and want to set up a solid system now.

asked by Suesan T.  –  October 27, 2013
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