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Overseas common - AAMI TIR 45:2012 describing AGILE practices within the improvement of clinical equipment software program. This regular has been lately well-known by way of US FDA.

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Additional resources for Guidance on the use of AGILE practices in the development of medical device software

Sample text

Changes that AGILE brings to a robust and effective quality management system should not diminish or give the perception of diminishing the effectiveness of the established system. Changes should be made within the requirements of regulations, regulatory guidance, and standards and, therefore, should not raise undue concern among regulators. When AGILE is used in the context of an established quality management system, apply AGILE practices in a way that does not disrupt the established system.

Single-user license only. Copying, networking, and distribution prohibited. ” 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.

In AGILE ’s INCREMENTAL / EVOLUTIONARY process, activities are “turned 90 degrees,” showing that the activities are executed in parallel with each other. Although not demonstrated by the diagram, in actuality, the process activities can also be executed in any imaginable combination of sequence, parallelism, and feedback loops. The shading of the activities in the STORY section shows that the activities can sometimes blur together into an indistinguishable group. T EST - DRIVEN DEVELOPMENT ( TDD ) concepts suggest that testing activities should sometimes come before definition, design, and implementation.

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