Quality & Certifications
Diagsensor Medical customizes quality control systems based on the market demand for client products, ensuring compliance with international standards. Through strict quality management, we ensure consistent delivery. With internal feedback mechanisms and regular reviews of procedures, we maintain high standards in our systems:
Quality & Certifications
Comprehensive documentation support, including specification control as required by clients
Ongoing quality monitoring and trend analysis
A rigorous internal audit program that establishes corrective and preventive actions (CAPA)
Compliance with FDA requirements under GMP 21 PART 820 standards
Class 7 cleanroom production environment control
Cleanroom temperature and humidity control
UDI compliance: Providing packaging services in accordance with global medical device UDI regulations. Product traceability is systemically recorded, preserved, and relevant traceability information is provided to clients as required
Protecting client intellectual property is the foundation of our business model. We do not develop independent branded products, ensuring no competition with clients. Professional information security software is used to authorize, control, and record documents. Employees are trained to respect client intellectual property and information protection.
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