Establishing Compliance and Operational Excellence at Almajarah Medical Devices (Suture Manufacturing Facility)
Client: Almajarah Medical Devices
Sector: Medical Device Manufacturing (Sutures)
Location: Iraq
Background
Almajarah, a surgical suture manufacturer, faced operational challenges that resulted in a temporary halt in production. To resume operations and meet regulatory expectations, the facility required a complete upgrade of its quality systems, documentation, and validation framework in line with ISO 13485 and GMP requirements.
Objective
To rebuild the quality management system and technical qualification framework, ensuring full regulatory compliance and enabling the safe, compliant resumption of manufacturing activities.
Scope of Work
End-to-End Compliance & Qualification Program
Challenges Identified
Solutions Implemented
System Rebuilding & Technical Qualification
Results Achieved
Regulatory Compliance & Operational Restoration
Conclusion
Agon’s strategic system rebuild and qualification approach transformed Almajarah into a compliant, operational, and audit-ready medical device manufacturer. The project demonstrates effective integration of GMP and ISO 13485 excellence within the suture manufacturing sector.
