Series
Complex questions deserve a closer examination.
Connected articles exploring software development, quality systems, evidence and the responsibilities that follow a medical product throughout its life.
SaMD development and change control
How cardiovascular software teams connect development, validation, and regulatory decisions to release changes with confidence.
QMS & software
The code is ready. Is the SaMD change ready for release?
October 22, 2026
A passing build does not settle every release question. Connect clinical impact, evidence and submission decisions before committing to a SaMD change.
Read article : The code is ready. Is the SaMD change ready for release?