MEDTECH
1–3 FTEs
Reallocated from repetitive review
70%
Reduced manual monitoring and initial analysis effort
The challenge
Adverse event monitoring is continuous, high-volume, and time-sensitive. Asteri enables life sciences and MedTech teams to deploy an AI agent that executes the operational work of surveillance — so safety and quality teams can focus on triage, investigation, and action.
The Solution
From: 100% Human-Led Adverse Event Monitoring
In traditional post-market surveillance, teams manage the entire workflow manually:
Analysts periodically monitor regulatory sources and search for new reports
Reports are downloaded, exported, and consolidated across multiple sources
Data is manually cleaned, normalized, and entered into trackers or spreadsheets
Event Descriptions are reviewed one-by-one to interpret and tag issues
Teams manually identify trends across products, geographies, and time windows
Weekly or monthly summaries are built by hand
Auditability and traceability rely on manual documentation discipline
To: AI-Powered Monitoring with Humans in the Loop
With Asteri, an AI agent takes over the repetitive operational work while humans retain full oversight and decision authority.
Tasks handled by the Asteri AI agent:
Continuously monitor approved regulatory sources (e.g., FDA databases and other regulatory sites)
Ingest, de-duplicate, and normalize new reports into a structured format
Extract key fields from Event Descriptions (symptoms, device/product terms, failure modes)
Detect recurring keywords and emerging themes across incoming reports
Cluster reports by product, adverse event type, geography, suspected root cause, and time window
Flag potential safety signals and generate evidence-backed summaries for review
Maintain a complete audit trail of source links, extracted data, and agent outputs
Escalate findings to human teams based on configured thresholds (severity, frequency, novelty)
Tasks retained by human teams:
Review and validate flagged signals
Conduct investigations and root-cause analysis
Assess risk and determine escalation actions
Manage regulatory communication and reporting
Execute corrective and preventive actions (CAPA)
The Impact
Reduce manual monitoring and initial analysis effort by up to 70%
Reallocate 1–3 FTEs from repetitive review to higher-value investigation and decision-making
Improve speed and consistency of safety signal detection
Enhance traceability, audit readiness, and regulatory confidence
Enable always-on surveillance without increasing headcount
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