Chip lifecycle / Checklists / Medical lifecycle / Post-market Surveillance, Vigilance & Change Control: stage exit checklist

Post-market Surveillance, Vigilance & Change Control: stage exit checklist

Run by the post-market surveillance lead before the stage's closing gate, to confirm its outputs, reviews and decisions are complete.

1. Exit conditions

MustThe periodic surveillance report is issued with trends and conclusions.
Evidence
Post-market surveillance report
MustReportable events were reported within the regulation's time limits.
MustThe risk management file is updated with production and post-production information.
Evidence
Risk management file
MustChanges made in the period have regulatory significance assessments.
Evidence
Regulatory change assessment
SeeDecision: Significance of a design or supplier change Flow: Engineering change request and impact assessment

2. Gate criteria met

MustPost-market surveillance report for the period: issued.
Evidence
Periodic surveillance review evidence pack

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