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Medical Devices · Workflow
Post-market surveillance and adverse event reporting
Automates the collection, analysis, and reporting of adverse events from medical devices to regulatory authorities while updating quality management systems. Ensures compliance with FDA and international reporting requirements within mandated timeframes.
Workflow Trigger
Adverse event report received from healthcare provider, patient, or internal source
Visual Flow
Each node represents an automated step. Connections show how data and decisions move through the workflow.
Step-by-Step Breakdown
Detailed explanation of each automated stage in the workflow.
- 1Trigger
Receive adverse event notification
System captures adverse event data from multiple sources including customer complaints, clinical reports, or regulatory submissions. Initial data validation and case creation occurs automatically.
- 2Action
Extract and standardize data
AI processes unstructured adverse event information and maps it to MedDRA coding standards. Missing required fields are flagged for manual completion.
- 3Decision
Assess regulatory reporting requirements
System evaluates event severity, device classification, and jurisdiction to determine if FDA MDR, EU EUDAMED, or other regulatory reporting is required. Timeline and priority levels are automatically assigned.
- 4Action
Generate regulatory submissions
Automated creation of FDA Form 3500A, EUDAMED reports, or other jurisdiction-specific submissions. Documents are populated with standardized adverse event data and device information.
- 5Action
Update quality management records
Case information flows into CAPA systems and risk management databases. Trending analysis is performed to identify potential systematic issues requiring corrective action.
- 6Action
Submit to regulatory authorities
Completed reports are electronically transmitted to FDA, notified bodies, and international regulators within required timeframes. Submission confirmations are tracked and stored.
- 7Output
Generate compliance documentation
System produces audit trails, submission receipts, and management dashboards showing adverse event trends and regulatory compliance status. Stakeholders receive automated notifications of completed submissions.
Outputs
- FDA MDR and international regulatory submissions
- Updated CAPA and risk management records
- Adverse event trending and compliance dashboard
Key Metrics
- Regulatory submission timeliness (% within required deadlines)
- Adverse event case processing time
- Post-market surveillance compliance rate
Tools & Integrations
OA
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