Category: QMS & software
CAPA effectiveness: evidence that the problem stayed corrected
Implementing a correction is only part of the evidence. A useful CAPA effectiveness review connects the cause, the changed control and enough post-change observation to support closure.
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.
Design transfer for connected cardiovascular devices
A working development unit does not establish production readiness. Design transfer makes hardware, software configuration and acceptance decisions reproducible beyond the engineering team.
A quality system that follows the development work
Requirements, risks, tests, and changes need a useful relationship in everyday engineering.
Traceability should explain the product
Connect requirements, risk controls, design outputs, and tests so the relationships remain useful during change.