Quality & Certifications
Diagsensor operates an ISO 13485-certified quality management system. We establish quality controls based on customer specifications, product requirements, and applicable regulatory requirements in target markets. Through process monitoring, internal audits, and regular reviews, we support consistent product quality and continuous improvement.
Quality & Certifications
Quality Management & Documentation
We maintain controlled documentation and product specifications to support manufacturing consistency and traceability. Internal audits, quality monitoring, and trend analysis help identify opportunities for improvement and guide corrective and preventive actions (CAPA).
Controlled Manufacturing Environment
Manufacturing is carried out in an ISO Class 7 cleanroom, with ongoing monitoring of key environmental parameters, including temperature and humidity, to maintain controlled production conditions.
Traceability & UDI Support
We maintain material, production, and inspection records to support product traceability. Packaging and labeling services can be provided to support applicable Unique Device Identification (UDI) requirements, with relevant traceability documentation available to customers upon request.
Confidentiality & Intellectual Property Protection
Protecting customer intellectual property and confidential information is fundamental to our partnerships. We use controlled document access, defined user permissions, and activity records to safeguard customer information. Regular employee training reinforces confidentiality and information security practices.
Videos
Watch the video，Learn more about our products and services.Diagsensor is dedicated to the research and development of ultra-micro sensors for vital signs monitoring
Learn MoreSocial Media
Our Social Media Channels Keep You Informed.
