Quality Assurance

Quality is the foundation of Gemore's success and the core of our commitment to customers worldwide.

Gemore operates under an ISO 13485 certified Quality Management System and is MDSAP certified by SGS (SGS United Kingdom Ltd.). We have also obtained Taiwan QMS certification (formerly GMP), ensuring that our products are designed and manufactured in accordance with international medical device quality requirements.

Our quality management system covers every stage of the product lifecycle, including:

• Product Design and Development
• Supplier Qualification
• Incoming Material Inspection
• Manufacturing Process Control
• Product Testing and Inspection
• Risk Management
• Corrective and Preventive Actions (CAPA)
• Traceability
• Continuous Improvement
• Customer Satisfaction

Our commitment to quality enables us to provide safe, reliable, and effective medical devices that meet customer expectations and applicable regulatory requirements worldwide.