Handling Development in a Medical Device World (Part 8)

CONTINUOUS INTEGRATION BUILDS To answer the first question, before it is even asked: Yes, a software project should have continuous integration (CI) builds. This goes for projects with a large team as well as projects with a small team. While the CI build is very useful for a large group to collaborate there is tremendous… Continue reading Handling Development in a Medical Device World (Part 8)

Handling Development in a Medical Device World (Part 7)

USE THE ISSUE TRACKING SYSTEM FOR ALL PROJECT DESIGN AND DEVELOPMENT I propose that it is not enough to simply leave functional requirements in the software requirements specification document. This does not provide sufficient tracing, nor does it provide a clear path from idea to functional code. Here are the steps that I suggest: All… Continue reading Handling Development in a Medical Device World (Part 7)

Handling Development in a Medical Device World (Part 6)

So what’s so great about Redmine? The power of the wiki: Your documents have all of your project management details, work instructions, use cases, requirements and so on. Again, I think this information can be placed into the wiki, but that may be a step that not everyone is comfortable taking. That said, all developer… Continue reading Handling Development in a Medical Device World (Part 6)

Handling Development in a Medical Device World (Part 5)

RELEASING SOFTWARE When software is released it is typically given some kind of version number (e.g., 1.0). This is good, but it doesn’t tell us the specifics of what went into that build. It’s a good idea to include the Subversion changeset number somewhere in the release so that we always know EXACTLY what went… Continue reading Handling Development in a Medical Device World (Part 5)

Handling Development in a Medical Device World (Part 4)

VERSION CONTROL The earliest phase of any software project is the planning phase. At this stage, people involved with the project have meetings and discuss some very high level needs. There are probably some presentations and documents that are created. Project management plans have not been developed, but they should be thought about. And as… Continue reading Handling Development in a Medical Device World (Part 4)

Handling Development in a Medical Device World (Part 3)

ONE APPROACH After that long introduction, my desire is to write about one approach to handling design and development activities of a software project. This is an approach that works well for any software project, not just one in which a 510K is being pursued. Given the fact that the biggest needs are for good… Continue reading Handling Development in a Medical Device World (Part 3)

Handling Development in a Medical Device World (Part 2)

WHAT WENT WRONG? So what went wrong during this audit? The obvious and most simple answer is that I wasn’t prepared. Yet, even as I reflect, to this day I’m not entirely sure what the auditor wanted to know. The project manager was irritated with me for not understanding the questioning, yes, but what was… Continue reading Handling Development in a Medical Device World (Part 2)