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Solutions for Post-Market Surveillance Teams

From Complaint Handling to Vigilance — All in One Compliant Framework.

Post-Market Surveillance is no longer just complaint logging.
Regulators expect manufacturers to systematically collect, analyze, trend, escalate, and act on post-market data across the entire product lifecycle. Regtech provides PMS teams with an end-to-end, risk-linked, and audit-ready PMS framework — covering complaint handling, vigilance, trend analysis, regulatory reporting, and continuous feedback into risk management, CAPA, and design improvements.

Centralised Complaint & Feedback Intake

One entry point. Complete traceability.

  • Centralized capture of complaints from Customers, distributors, sales teams, service engineers, and field reports.
  • Unique complaint IDs with date, source, and product identification
  • Auto-linkage to Product, model, UDI, batch/lot, and serial numbers
Eliminates fragmented PMS data and ensures full traceability from day one

Complaint Investigation & Root Cause Management

From intake to conclusion — fully documented.

  • Structured investigation workflows with defined responsibilities
  • Root cause analysis tools linked to Manufacturing, design, labeling, or use-related issues
  • Mandatory documentation of investigation outcomes

Demonstrates controlled complaint handling as required by regulators

Vigilance & Adverse Event Escalation

Right events. Right timelines. Right authorities.

  • Automated identification of events requiring regulatory reporting
  • Built-in escalation logic for: serious incidents, Adverse events , Field safety corrective actions (FSCA)
  • Region-specific vigilance workflows:EU MDR (MDR Articles 87–90), US FDA (21 CFR 803), Other global authority requirements.
Prevents missed or delayed vigilance submissions

Trend Analysis & Signal Detection

Detects issues before regulators do.

  • Automated dashboards for: Complaint frequency, Failure modes, Repeat issues by batch, product, or geography
  • Threshold-based alerts for statistically significant trends
  • Early warning signals for emerging risks
Enables proactive corrective action instead of reactive firefighting

Field Actions, Recalls & FSCA Support

Controlled execution of field safety actions.

  • Structured workflows for: Field Safety Notices (FSN), Recalls and corrections, Customer communication tracking

  • Documentation of: Affected products and customers, Actions taken and completion status
  • Full audit trail of decisions and approvals
Demonstrates controlled handling of high-risk post-market actions

Audit-Ready PMS Documentation

Always inspection-ready, without the scramble:

  • Auto-generate PMS Reports and Trend Reports.
  • Supports PSUR (Periodic Safety Update Reports) and PMCF (Post-Market Clinical Follow-up) needs.
  • Role-based secure access for PMS, QA, and auditors.
Eliminates last-minute report compilation

Centralized Regulatory Records

All approvals, dossiers, commitments, and letters:

  • Stored securely in one platform
  • Easily searchable with complete traceability

Be ready for any inspection — even the surprise ones. Role-based access control for RA leads, collaborators, and auditors.

Consistency from source to submission.

Post-market data is not just evidence — it is intelligence. Regtech transforms PMS from reactive reporting into a proactive compliance and risk-control engine.