Complaint, Vigilance & Post-Market Readiness
A Complaint File Can Expose the Entire QMS
Complaint handling is one of the most revealing MDSAP audit trails because a single record can touch investigation, adverse-event reporting, CAPA, risk management, supplier quality, design change, labeling, field action and management review. Weak reportability logic or delayed escalation can quickly become a regulatory concern rather than a documentation issue.
Our Complaint & Vigilance Support Includes
- Complaint intake and triage protocols
- Complaint investigation depth and root cause adequacy
- Reportability assessment across applicable jurisdictions (FDA eMDR, Health Canada, TGA, ANVISA, MHLW)
- Timeliness and escalation controls against statutory deadlines
- Adverse-event reporting evidence and transmission logs
- Advisory notice / field safety corrective action (FSCA) readiness
- Statistical trend and early warning signal analysis
- CAPA linkage and trigger criteria
- ISO 14971 Risk-management feedback and risk-file updates
- Supplier and manufacturing investigation interfaces
- Label / IFU change linkage based on user feedback
- Management review escalation and vigilance metrics
- Distribution and traceability records for field actions
What the Auditor Is Really Testing
- Whether every complaint is evaluated consistently against documented procedures
- Whether reportability decisions are documented and jurisdiction-aware
- Whether investigations are proportionate to device risk and patient harm
- Whether repeat issues trigger statistical trending and automatic CAPA
- Whether post-market information feeds directly back into risk and design processes
- Whether field action decisions can be executed rapidly and traced to individual serial/lot numbers
How NKB Regovanta Approaches It
We sample complaint records the way an auditor does: from intake through closure. The file must show what happened, how the event was investigated, whether it was reportable in each applicable market, whether risk changed, whether CAPA was needed and whether a field or design action followed. Missing links are treated as system weaknesses, not clerical omissions.
Harmonize Multi-Country Vigilance & Reporting
Protect your MDSAP certification with bulletproof adverse event reporting logic and complaint investigation workflows.