What I am proposing in this article is something that I, personally, have never done. In my positions as a software lead, architect, developer and software quality analyst, I have worked only with a DHF as a particular folder with specific subsets of documentation within. This approach has always resulted in a documentation nightmare. I’ve… Continue reading Continuous Integration on Software Medical Device Projects, Part 5
21 CFR Part 820 – DHF Requirements 820.30(e) Design History File (DHF) means a compilation of records which describes the design history of a finished device. –Device Advice: Regulation and Guidance, Software Validation Guidelines, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance Medical device software is audited and controlled by standards defined by FDA, specifically 21 CFR parts 11 and 820. Many… Continue reading Continuous Integration on Software Medical Device Projects, Part 4
Jenkins CI For the purposes of this article, the focus will be on one specific continuous integration build tool, Jenkins CI. This is one of the more popular (open source) tools available. Jenkins CI (the continuation of a product formerly called Hudson) allows continuous integration builds in the following ways: 1. It integrates with popular… Continue reading Continuous Integration on Software Medical Device Projects, Part 3
Continuous Integration refers to both the continuous compiling and building of a project tree and the continuous testing, releasing and quality control. This means that throughout the project, at every stage, the development team will have a build available with at least partial documentation and testing included. The CI Build is used to perform certain… Continue reading Continuous Integration on Software Medical Device Projects, Part 2
I’m currently working on an article about continuous integration on software medical device projects, and how the CI environment can actually be used to solve many of the design and tracing requirements that must be dealt with on such a project. I’m not finished, but I wanted to post a little bit here. Here goes.… Continue reading Continuous Integration on Software Medical Device Projects, Part 1
When writing software for medical purposes, that software may or may not be subject to FDA scrutiny. We may or may not be required to submit for a 510k. What does this mean? How do we know? Its all a little confusing. As I considered a series of articles on the subject, I wanted to… Continue reading What is a Software Medical Device?
The Traceability Matrix A critical factor in making unit tests usable in an auditable manner is incorporating them into the traceability matrix. As with any test, requirements, design elements and hazards must be traced to one another through use of the traceability matrix. The project team must document traceability of requirements through specification and testing… Continue reading Valuable Unit Tests in a Software Medical Device, Part 8