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PubMed · 16419920

Useful US guidance on device software.

Maria Donawa
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Abstract

The use of software in medical devices and their accessories has led to significant improvements in clinical diagnosis and treatment of a vast range of illnesses. However, to benefit patients and users, device-related software must be properly developed and tested before use. This article discusses a United States guidance document that describes the type of documentation needed to show that this has been done.

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Equipment and SuppliesGuidelines as TopicSoftwareSoftware DesignUnited StatesUnited States Food and Drug AdministrationJournal Article

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Maria Donawa. 2005. Useful US guidance on device software.. https://pubmed.ncbi.nlm.nih.gov/16419920/

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