Agile Development of Medical Devices

On-Demand: Aired Live May 16, 2012

Agile methods have become popular in software development because they emphasize effective project governance in the face of new or changed project information. These changes may be in requirements, target platform, customer needs, regulatory changes, or any other project related data. Traditional safety-critical systems development is fundamentally based on the premise that it is possible to fully plan out a project so that every aspect of the project is stable during system development. However, we clearly know that there are things that we just don’t know at the start of a project that come as a surprise later and many of the things we do know will change during the development cycle. Agile methods offer a solution to this dilemma, but must be applied carefully when developing safety-critical and high-reliability systems such as medical devices. This talk, by the well-known author of Real-Time Agility and other books on embedded development, identifies the agile key practices that can help you develop your medical systems safely and effectively, improve product quality, and generate the evidentiary data for regulatory approval while allowing you to be agile in the face of change.

Attendees will learn how agile methods can be applied to the development of high-reliability and safety critical medical device development. Covered topics include use of modeling, agile best practices, development of evidence for regulatory approval, and adherence to IEC 62304.

Bruce Powel Douglass - Chief Evangelist for IBM

John McHale, Editorial Director,
OpenSystems Media
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