By AAMI

Foreign common - AAMI TIR 45:2012 describing AGILE practices within the improvement of clinical gadget software program. This usual has been lately famous by way of US FDA.

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

Sample text

If the organization’s high-level process documentation was written to allow or encourage an INCREMENTAL – EVOLUTIONARY lifecycle, that documentation might need little or no change to align with the principles and practices of AGILE . If that documentation mandated or assumed a more linear, WATERFALL lifecycle, some changes will be necessary to accommodate AGILE ’ S INCREMENTAL – EVOLUTIONARY lifecycle. More detailed process documentation that exists in project plans will likely change to address the detailed practices of AGILE .

29 following sections, designers can avoid those misalignments.

Quality system regulations and guidance do not address the process of creating contracts between manufacturers and customers, so, in that regard, this value statement demands no unique interest from the medical device software world. More important to regulatory agencies and manufacturers is the process for identifying the needs of customers and patients. Understanding user needs and the intended use of the software product, and ensuring that the software is designed and validated for that use, is a vital element of creating a safe and effective product.

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