What is a "use case"?

Lee Chickering
Lee Chickering
  • Updated

21 CFR 820.30g states: 

"Design validation shall ensure that devices conform to defined user needs and intended uses..."

Additionally, IEC 62304 states:
"The manufacturer shall document the intended use of the particular medical device being considered. The intended use should take into account information such as the intended medical indication, patient population, part of the body or type of tissue interacted with, user profile, use environment, and operating principle". 

User needs, use cases, and intended uses, at the highest level, are configuration items of type Requirement that describe how users interact with a medical device to achieve a particular goal, what the end users expect in the final product, and identify what the users want or require from the product or system. 

A use case has not necessarily been defined in these standards / regulations. However, a manufacturer may determine that they'd like to define use case requirements. In comparison to a user need and intended use, the use case may be a specific instance of how the product or software will be used to meet a user need within the scope of its intended use. It may describe interactions between the user and the system to provide a narrative of how a particular system could be used. They may illustrate a practical application of how the product fulfills user needs and achieves the intended use through these specific interactions. 

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