Quality and Product Certification
Quality and Product Certification
At Sandstone Medical, product quality is our foremost commitment to customers. We ensure every device meets strict health-and-safety standards and complies with the regulatory requirements of each market we serve. Our advanced production lines, in-line image-inspection systems, and TPM-based quality-management programme underpin this promise.
System & Regulatory Certifications
- China Medical Device GMP System Certification
- EN ISO 13485:2016—International Quality-Management System for Medical Devices
- MDSAP Quality System Certification (United States, Canada, Brazil, Australia, Japan)
- China NMPA Device Registration
- U.S. FDA 510(k) Premarket Notification
- CE Marking (European Union)
- Device registrations and certifications in the United Kingdom, Canada, and additional jurisdictions
