April 29th, 2016 by inflectra
fda medical devices cfr part 11 hipaa
In this morning's Washington Post, there was an article about 'The new sheriff in town' describing how the new biotechnology and drug screening startups in Silicon Valley are colliding with the conservative, formal testing philosophy of the United States Food & Drug Administration (FDA).
This article was interesting because we have many customers already using SpiraTest / SpiraTeam to help manage their formal FDA testing and validation. In fact OnShore Technologies has partnered with us to create a version of SpiraTeam called Validation Master that explicitly uses the powerful testing and requirements traceability features of Spira to help customers validate their systems and devices for use with patients.
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