The series of articles is focused on the agile software development of medical devices (e.g. software that works with hardware, that is heavily regulated and that has to deal with the unpredictable magic of biology). I intend to deal with various aspects of the development lifecycle: quality assurance, specification, architecture, build, testing, people, project management, pure agile stuff.

The targeted audience is made of managers and project managers. I hope there is some useful information for developers, architects, business analysts, testers and regulatory affairs specialists too.

 

Some of the views expressed here are very personal and are not, by any means, endorsed by any of my past or present employers. Keep in mind that I have my biases: these posts should be considered a starting point for your own reflection in finding the right processes in your context. I’m just trying to give the kind of advice from the trenches that I would have liked to receive when I started my first medical device software project.