SteriLance always prioritizes product quality, which is our bottom line and commitment to our customers. We ensure that our products meet health and safety requirements and comply with the regulatory requirements in markets where our products are sold through leading production processes, advanced online image inspection and a TPM quality management system.
■ China Medical Device GMP System Certified
■ EN ISO 13485 : 2016 International Medical Device Quality Management System Certified
■ MDSAP Quality System Certified (a medical device audit program participated in by the United States, Canada, Brazil, Australia and Japan)
■ UL 21 CFR Part 820 Medical Device Quality Management System Certified
■ Registered with China NMPA (National Medical Products Administration)
■ U.S. FDA 510(k) Premarket Notification completed
■ MDR EU CE officially certified
■ Medical device registration and certifications in UK, Canada, India and other countries