Syrma Johari MedTech supports medical device OEMs through end-to-end complaint handling, covering intake, triaging, investigation, root cause analysis, and regulatory reporting. With strong quality processes and global compliance expertise, SJML enables efficient complaint management while ensuring audit readiness and regulatory alignment.
A structured program management and SLA-based approach ensures timely investigations, consistent documentation, and efficient resolution while maintaining regulatory compliance.
SJML supports end-to-end complaint management—from intake and triage to investigation, risk evaluation, and regulatory reporting. Teams integrate within client QMS or operate as an extended regulatory function for timely, compliant, and defensible outcomes.
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.
Complaints Supported
CAPAs Executed
Medical Devices | Pharma | OTC | Cosmetics
Investigations
Investigations
Traceability
Partner with Syrma Johari MedTech to build structured complaint management programs that support regulatory compliance and patient safety.
