regulatory compliance

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.

Agile at Scale: What it Takes on the Right-Hand Side of the Chasm

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Now that Agile has crossed Moore’s technology adoption chasm we’re finding that we need to address many of the scaling issues that we’ve mostly ignored until now. There is more to scaling agile than addressing the need of large or distributed teams. This presentation overviews the challenges and issues which the agile community must address in order to scale agile techniques and philosophies to meet the needs of modern organizations. Experiences and potential solutions from within IBM and several customers will be discussed, including both what works and what doesn’t.

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