Dojo Five – Modern Firmware Software Consulting
Modern Firmware Software Consulting and Tools
Start with the process, Finish with the work To obtain regulatory approval for medical device software, you'll need to comply with the IEC-62304 Medical Device…
Continue reading → Start with the Process, Finish with the Work
Software Bill of Material (SBOM) for Medical Devices Modern devices are becoming increasingly more complex. Higher user expectations for product features and connectivity have developers…
Continue reading → Software Bill of Material (SBOM) for Medical Devices
Part I provides some background to IEC-62304. Part II provides a slightly more in-depth look at some of the specifics. The IEC 62304 Medical Device…
IEC-62304 Software Lifecycle requires a lot of self-reflection to scrutinize and document your development processes. There is an endless pursuit of perfection when it comes…
Continue reading → IEC-62304 Medical Device Software – Software Life Cycle Processes Primer – Part 1
Creating a proof of concept device is cheap. Creating a device to be submitted through the regulatory path is not, even when it's the exact…
Continue reading → How much is that medical device going to cost!?!??!
Accelerate your medical devices' embedded software development using cultural, process, and tool changes such as an embedded CI pipeline.