PubMed · 12030100
FDA final guidance on software validation.
Abstract
The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for its importance.
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Maria Donawa. 2002. FDA final guidance on software validation.. https://pubmed.ncbi.nlm.nih.gov/12030100/
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