ISO 13485

Arabella for Medical Technologies is proud to announce the achievement of ISO 13485 Certification by DNV.GL, demonstrating our commitment to the success of our medical industry customers. Our process controls, documentation, and quality standards now meet or exceed all ISO 13485 requirements.

ISO 13485 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. It focuses on risk management activities during product development and guides specific requirements for verification of effectiveness of corrective and preventive actions. It demonstrates a commitment from management for quality throughout the product development life-cycle and the product’s lifespan with customers.

The Quality team at Arabella implemented and maintained the quality management system for an internal audit, which then led to final certification of ISO 13485. Arabella is one of the few medical devices companies to achieve this certification in Jordan, and the only surgical drapes and gowns factory in Jordan.

We believe that our decision to become ISO 13485 certified is a proactive one that not only anticipates to the demands of our customers, but also demonstrates our commitment to providing quality services to all our customers in the medical industry.

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