Quality Policy

At SCI Health, UAB, we are committed to the design, development, manufacture, and distribution of medical devices that are safe, effective, and compliant with applicable regulatory requirements. We establish, implement, and maintain a Quality Management System to ensure consistent product quality and to support continuous improvement.

To achieve these objectives, we adhere to the following principles:

1. Regulatory Compliance
We ensure compliance with all applicable regulatory requirements and relevant international standards throughout the entire lifecycle of our medical devices.

2. Safety and Performance
We prioritize patient safety and product performance by applying controlled and validated processes in design, development, and manufacturing.

3. Quality Monitoring and Effectiveness
We monitor product performance and the effectiveness of our Quality Management System through defined metrics, analysis, and periodic review.

4. Customer Focus
We collect and evaluate customer requirements and feedback and incorporate them into product and process improvements.

5. Continuous Improvement
We are committed to the continual improvement of our products, processes, and Quality Management System through risk-based thinking and active employee involvement.

We believe that consistent adherence to these principles enables us to deliver reliable, high-quality medical devices and contribute to improved healthcare outcomes.