Built for Global Programs, Audit Readiness, and Repeatable Quality
Globalcare operates with a quality-driven system supported by certifications, process control, disciplined inspection, and manufacturing execution. Our quality system is designed to deliver reliability, traceability, and consistent performance across markets.

Quality Management System
Quality at the Core
Quality is central to how Globalcare develops and manufactures home healthcare devices. From product development to production, our processes are designed to support consistency, compliance readiness, and long-term reliability.

Compliance and Certification
• ISO 13485 Quality Management System
• ISO 14001 Environmental Management
• ISO 50001 Energy Management
• BSCI social compliance audit
• CE / MDR coverage for existing product lines
• FDA audit track record
• FDA 510(k) clearance for selected products
• NMPA certifications for mainstream models

Quality Execution in Manufacturing
• Product and process validation
• Incoming inspection
• In-process inspection
• Final inspection
• Automation and in-house injection molding for stronger process control
• Traceability and documentation support
• Continuous improvement practices

What This Means for Our Partners
• Higher confidence in scale-up and supply stability
• Stronger audit and registration readiness
• More consistent performance across orders and markets
• Better support for regulated product programs
• More reliable long-term cooperation