When medical software fails quietly
How stale data, incorrect units, patient mismatches and misleading displays can produce plausible but wrong outputs—and how to detect and control these quiet failures.
Software & SaMD
Practical lifecycle guidance for embedded, cloud, mobile and software-only medical devices.
The algorithm is not the product
Why successful medical software requires evidence for the complete clinical product and workflow—not only the performance of its algorithm.
IEC 62304 and the medical-device software lifecycle
A practical introduction to IEC 62304, software safety classification and the evidence created across development and maintenance.