What is a configuration item?

Lee Chickering
Lee Chickering

IEC 62304 states: 
Configuration Item 
Entity that can be uniquely identified at a given reference point. This could be any item defined by the manufacturer that is part of the development process and needs to be managed and controlled. 

By thorough analysis of IEC 62304 and FDA standards, Ketryx has identified the following default configuration items: 

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