SOFAP Medical Information

SOFAP is a Tunisian-based manufacturer and industrial subcontractor specializing in single-use sterile medical devices. With decades of experience, the company supports European and international partners in the development and production of high-quality medical solutions. Our expertise covers the entire manufacturing process, including plastic injection, tube extrusion, assembly, packaging, and sterilization, all in strict compliance with applicable regulatory and quality standards. SOFAP operates under a robust quality management system and holds the following certifications: NF EN ISO 13485:2016 ISO 11135:2014 (Ethylene Oxide Sterilization) EC Certificate We are currently progressing toward MDR certification to further strengthen our compliance with European regulatory requirements. Our industrial capabilities, combined with modern European equipment, enable us to offer flexible and scalable production—from pre-series to mass production—while ensuring consistent quality and reliability. SOFAP Devices provides key advantages to its partners: competitive cost structure, skilled workforce, strong quality culture, and strategic proximity to European markets. Our product portfolio includes a wide range of single-use medical devices and consumables, designed to meet the needs of healthcare professionals and industrial partners. Today, SOFAP exports to multiple regions, including Europe, MENA, and Africa, positioning itself as a trusted partner for OEM and private label medical manufacturing. Driven by continuous improvement and customer satisfaction, SOFAP Medical Devices is committed to delivering reliable, compliant, and high-performance solutions for the global medical industry.