Overseas regular - AAMI TIR 45:2012 describing AGILE practices within the improvement of clinical equipment software program. This normal has been lately well-known via US FDA.
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Additional info for Guidance on the use of AGILE practices in the development of medical device software
Although it is necessary to have an environment where design controls exist, it is also necessary to allow engineers and designers to think, to create, to solve problems, and to implement great solutions. A criticism of this value is that it can lead to a lack of discipline. If this value were taken to an extreme, that criticism might be valid, but when applied with balance, a better discipline can result. Documented processes and supportive tools bring discipline to a development process by codifying procedures and behaviors that have been deemed important.
Saying “we are AGILE , we don’t need design documentation” is not a defendable position in the medical device software world. More importantly, effective documentation can help a software team produce a safe and effective product. A GILE should not be used as a reason to diminish the value of documentation. Instead, AGILE concepts should be applied to ensure that valuable documentation is produced and wasteful documentation is eliminated. ” Although this is a useful notion to highlight the importance of producing an audit trail, over-emphasizing it can lead to a checklist mentality where documentation is produced simply to satisfy some real or imagined requirement while providing no value to the development team.
Inputs must be "DONE enough" to begin the work. 3 Regardless of the chosen lifecycle model and the sequence of activities, it is important to ensure that inputs and outputs maintain a consistent state. 1). A GILE ’s INCREMENTAL approach emphasizes work on small pieces of functionality (a STORY ) that is meant to be completed within tight ITERATION boundaries. To maintain the consistent state of inputs and outputs, the simplest and most ideal exit criteria for a STORY are the following: • The STORY is not DONE until all the outputs and related inputs are DONE.