Quality and Product Certifications
At Sandstone Medical, we always prioritize the quality of our products, which is our main goal and commitment to our customers. We ensure that our products meet health and safety standards and comply with regulatory requirements in the markets where our products are sold. Our leading production processes, advanced in-line image inspection, and TPM quality management system all contribute to achieving this goal.
- China Medical Device GMP System certification
- EN ISO 13485:2016 International Quality Management System certification for medical devices
- MDSAP Quality System (a medical device audit program including participating parties - the United States, Canada, Brazil, Australia, and Japan) certification
- China National Medical Products Administration (NMPA) registration
- U.S. FDA 510(k) Premarket Notification
- CE marking
- Medical device registration and certification in the UK, Canada, and other countries
