Medical Devices; Quality System Regulation Amendments.¶
U.S. Food and Drug Administration. (2024). Medical Devices; Quality System Regulation Amendments. Federal Register.
Retired. This is not a bibliographic entry. Our extractor captured an inline prose definition from an article and stored it as a work. The concept is real; this registry record is a parsing defect. This entry is kept so the citations that pointed at it still resolve, and so the correction is visible rather than silent.
Cited by¶
1 citation across 1 artifact.
Each citation links to the sentence it supports in the citing article.
Mechanisms¶
- Corrective Action Effectiveness Retest
- Its strength is that it closes the loop the way real remediation demands: a corrective action is only worth what its effect is worth, and this is the mechanism that makes effect — not documentation — the closure criterion, the discipline behind a closed-loop corrective-action effectiveness check.
This sourceRequires manufacturers to verify or validate corrective and preventive actions to ensure that the actions are effective and do not adversely affect the finished device.
- Its strength is that it closes the loop the way real remediation demands: a corrective action is only worth what its effect is worth, and this is the mechanism that makes effect — not documentation — the closure criterion, the discipline behind a closed-loop corrective-action effectiveness check.
Verification¶
Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.
Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.
Was it audited? Yes. A second, independent pass read the citation against the article text and recorded a verdict.
Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.
See how references were verified.
Links previously used in the corpus¶
Before the registry existed this work was also linked 1 other way.
Registry ID ref:5398620e01dc · see in the full table