Complaint Handling & Vigilance support for Regulated Products

Structured complaint investigations aligned with ISO 13485, FDA 21 CFR 820.198, and EU MDR/IVDR.

Supporting complaint management across medical devices, pharmaceuticals, OTC drugs, and cosmetics to ensure compliant post-market surveillance and patient safety.

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Why Complaint Handling Matters?

Complaint handling is a critical component of post-market surveillance and regulatory compliance. Global regulations require manufacturers to investigate product complaints, assess patient risk, identify potential reportable events, and implement corrective actions.

Improper processing, investigation, or documentation of product complaints can result in warning letters, delayed approvals, distribution restrictions, and increased CAPAs.

Regulators expect structured intake, documented evaluation, timely investigation, root cause determination, and traceable closure under defined timelines.

A complaint system is not merely administrative; it is a regulated process that must withstand audit scrutiny.

End to End Complaints Handling Services

SJML supports manufacturers across the entire complaint management lifecycle—from complaint intake and triage to investigation, risk evaluation, and regulatory reporting.

Our teams work within client QMS environments or operate as an extended regulatory support function to ensure investigations are completed in a timely, compliant, and defensible manner.

Complaint Intake & Documentation

Structured complaint intake, case logging, and documentation aligned with internal QMS procedures and global regulatory requirements.

Initial evaluation of complaints to determine product risk, potential adverse events, and reportability requirements.

Root cause analysis through product review, engineering assessment, and manufacturing investigation where applicable.

Support for regulatory reporting including:

FDA MDR reporting

EU Vigilance reporting

Field safety corrective actions

Post-market surveillance documentation

Integration with CAPA systems to ensure corrective actions are initiated, documented, and tracked appropriately.

Complaint data analysis to identify recurring issues, emerging safety signals, and potential product improvements.

Proven Complaint Investigation Experience

15000+ Complaint investigations supported

300+ CAPA investigations executed

Multi-industry Devices • Pharma • OTC • Cosmetics

Global Regulatory reporting support

Engineering-led Technical investigation capability

Integrated Complaint → CAPA → Risk management

Why Manufacturers Partner with SJML

Regulatory Expertise

Teams experienced in global regulatory frameworks and vigilance requirements.

Structured Investigation Frameworks

Standardized workflows that ensure consistent, defensible complaint investigations.

Scalable Support

Capability to manage high complaint volumes during product launches or field events.

Integrated Engineering & Manufacturing Expertise

Ability to connect complaint investigations with design, engineering, and manufacturing root cause analysis.

Reduce Audit Risk and Improve Investigation Quality

Partner with Syrma Johari MedTech to build structured complaint management programs that support regulatory compliance and patient safety.

Speak with our QARA experts