Useful US guidance on device software.
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004864:Equipment and Supplies; D017408:Guidelines as Topic; D012984:Software / Q000592:standards*; D012985:Software Design; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards