Quality Assurance and Regulatory Affairs
Complaints Management for MedTech Products
Ensuring Regulatory Compliance & Consistent Customer Satisfaction
Syrma Johari MedTech provides comprehensive complaint management services for medical devices, in vitro diagnostics (IVDs), and Cosmeceuticals. Our end-to-end product complaint handling solutions combine regulatory expertise with advanced process automation to achieve faster resolution times.
We help MedTech manufacturers across the entire complaint lifecycle, providing timely responses and traceability across platforms. Our approach minimizes manual intervention and reduces operational costs, with 24/7 global support. In alignment with regional reporting timelines and applicable standards, we ensure every complaint is promptly captured, thoroughly assessed, and effectively resolved.
Product Complaints Management Services
Complaint lifecycle management from intake, investigation & closure
Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) execution
Regulatory reporting and documentation
Cross-functional coordination for efficient complaint resolution
Trends analysis and process improvements
Medical device translation services for multilingual documentation and reporting
Why Choose Syrma Johari MedTech
- Efficient and agile complaint handling led by seasoned Post-Market Surveillance (PMS) experts
- Proven ability to interpret complex device challenges and identify root causes
- Scalable workflows for varying complaint volumes and project demands
- Expertise spanning diverse therapeutic areas and digital health technologies (e.g., SaMD, IVDs, combination devices)
- Streamlined processes through Value Stream Mapping (VSM), delivering faster regulatory turnaround
- Proactive coordination with regulatory authorities to address Form 483 findings and ensure consistent compliance
- Seamless alignment with your business goals to enhance product quality and competitiveness