International standards

Agile development in a medical device company

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Developing software in a medical device company imposes a number of challenges on any methodology. There is a high level of dependency on hardware systems, long validation cycles and a strict regulatory environment which requires adherence to international standard and a high level of traceability. At Cochlear Limited (the largest cochlear implant manufacturer) we have been using agile software methodologies in this environment for just over two years.

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