program selection system

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. During this session Victor Rodrigues will explain how agile methodologies can be adapted to adhere to the emerging IEC62304 standard for software development in medical devices. Riaan Rottier, the project manager for the first software development project that used Scrum from start to finish, will then present on the software team’s experience, the lessons we learned, the tools we used and some of the challenges we still have to overcome.