R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Integration Phase - AGILE vs. Regulatory

An AGILE software development process allows for adaptive development through incremental changes in the software. This means that there are more releases and upgrades of the software in the field. Within the AGILE process there is time allotted for the integration phase. This means after development and initial testing of software features the team decides which features will be integrated into the core software. This obviously has to happen after development and successful testing but prior to official V&V testing and release.

Using AGILE in Medical Device Software Development

In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical devices. My client is constantly updating the software device by either adding new features or fixing defects. There is continuous development which means frequent pushes to market for this standalone software medical device. Because of this continuous improvement and continuous innovation....is the waterfall approach the best for development or will it hold up the innovation process?

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