Tag: SaMD
AI and sudden cardiac death: what should clinicians do with an ECG risk prediction?
A Nature study identifies an ECG signal associated with future sudden cardiac death. Its findings raise a practical development question: what action should a risk prediction support, and what evidence would justify it?
What determines the EU risk class of cardiovascular software?
EU software classification connects intended clinical use to the consequences of erroneous information. That reasoning also informs evidence, budget and conformity assessment.
Can your quality system reconstruct a SaMD release?
A quality system should make the evidence for a deployed SaMD version retrievable and understandable, across development tools and cloud operations.
The code is ready. Is the SaMD change ready for release?
A passing build does not settle every release question. Connect clinical impact, evidence and submission decisions before committing to a SaMD change.