MedTech PMS and vigilance workflows require teams to detect trends, assess complaints and escalate candidate safety issues with traceability. Biolevate supports first-pass surveillance and triage from post-market evidence with human review.
Faster PMS triage
Speed up first-pass review of complaints, vigilance reports and PMS inputs by structuring cases and linking them to device, risk and severity context.
Earlier safety trend detection
Detect recurring issue patterns across devices, lots, failure modes, markets and severity categories with consistent triage logic.
Traceable vigilance rationale
Keep every signal, escalation decision and PMS update rationale linked to source cases, risk files and reviewer decisions.
How it works
1
Ingest PMS and vigilance inputs — collect complaints, incidents, trend reports, service records, CAPA links and device metadata.
2
Classify cases and risks — tag failure mode, severity, device, lot, market, risk control and reportability context.
3
Detect trends and escalation candidates — compare new inputs with historical patterns to surface recurring issues and emerging safety signals.
4
Document triage and updates — generate source-linked summaries for PMS reports, vigilance review, CAPA and reviewer validation.
PMS/vigilance signal mapping: connect complaints and incidents to device families, failure modes, risk controls and post-market evidence.
Escalation-ready governance: route serious, recurrent or uncertain signals to human review with a complete source and decision trail.