At Tabeeb, quality assurance means establishing systematic confidence in product quality, safety and regulatory compliance throughout every stage of the product lifecycle—from design and manufacturing to inspection, packaging, release and distribution.
Guided by medical device standards, applicable regulatory requirements and quality management system principles, Tabeeb’s Quality Assurance Department plays a central role in monitoring, controlling and continuously improving organizational processes.
Our objective is to ensure that quality is not limited to final product testing. Instead, quality is built into process design, material selection, production facility development, equipment qualification, document control and post-market performance monitoring from the outset.
Guided by medical device standards, applicable regulatory requirements and quality management system principles, Tabeeb’s Quality Assurance Department plays a central role in monitoring, controlling and continuously improving organizational processes.
Our objective is to ensure that quality is not limited to final product testing. Instead, quality is built into process design, material selection, production facility development, equipment qualification, document control and post-market performance monitoring from the outset.
Quality Assurance at Tabeeb
Designing Processes for Consistent Quality
The Role of Quality Assurance at Tabeeb Vascular
Contributing to the design of quality systems and production facilities, and coordinating Design Qualification, Installation Qualification, Operational Qualification and Performance Qualification—DQ, IQ, OQ and PQ—to establish reliable manufacturing infrastructure.
Design and Facility Qualification
Managing the application, renewal and maintenance of required licenses and certifications from competent authorities, while supporting product compliance with applicable legal and regulatory requirements.
Regulatory Licenses and Certifications
Continuously reviewing and monitoring manufacturing and quality processes to verify the correct implementation of approved procedures and compliance with applicable standards and regulations.
Continuous Process Monitoring
Conducting PMCF activities, collecting feedback from healthcare centers at six- and twelve-month intervals, and analyzing post-market data to support improvements in product quality, safety and performance.
Post-Market Clinical Follow-up — PMCF
Quality Oversight and Documentation
Overseeing quality-control activities, managing documents and records, maintaining product traceability and safeguarding data integrity throughout the product lifecycle.
Risk and Nonconformity Management
Identifying and evaluating risks, managing nonconformities and deviations, and implementing corrective and preventive actions—CAPA—to prevent recurrence and support continuous process improvement.
Надёжные кардиоваскулярные решения для регионального здравоохранения
Tabeeb Vascular
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