Certifications & Compliance
Certified for Safety, Trusted by Professionals
Why lSO Certification ls Essential in Medical Device Repair Services
ISO certification isn’t just a formal requirement — it’s the foundation of professionalism, security, efficiency, and reliability in medical device aftercare.
For healthcare partners and institutions, ISO certification means:
- A quality management system built specifically for medical devices support services(ISO 13485:2016)
- Consistent service quality through controlled, auditable processes
- Compliance with international regulatory and safety standards
- Reduced risk in clinical use and supply chain reliability
- Confidence in long-term partnership, traceability, and accountability
Guangzhou Rongtao Medical Technology Co., Ltd operates under ISO 13485:2016 and ISO 9001:2015 certified quality management systems, ensuring that every process — from initial diagnostic assessment and precision repair to final testing and continuous improvement — meets the highest standards of precision, safety, and reliability.
Our certifications reflect a commitment not only to compliance, but to patient safety and operational excellence.
Safety. Quality. Trust.
At Guangzhou Rongtao Medical Technology Co., Ltd, every ultrasound repair service we deliver follows controlled, documented procedures under a quality management system aligned with applicable FDA QSR principles and certified to ISO 13485:2016 and ISO 9001:2015. Hospitals, distributors, and regulatory partners choose RT Medical because our operations emphasize controlled repair procedures, documented compliance, and consistent outcomes — built to meet the demands of regulated healthcare environments.
Our International Certifications
ISO 13485:2016
The ISO 13485:2016 certification confirms that Guangzhou Rongtao Medical Technology Co., Ltd operates under a quality management system specifically designed for medical devices. It ensures rigorous control over service processes, risk management, and traceability — providing confidence that every repair is conducted in accordance with internationally recognized medical quality and regulatory standards.
Certifcate Registration No: 381250398R0S.
Registered Address: Rooms 1209 and 1210, No. 266 Kefeng Road, Lianhe StreetHuangpu District, Guangzhou City, Guangdong Provice, China
ISO 9001:2015
The ISO 9001:2015 certification confirms that Guangzhou Rongtao Medical Technology Co., Ltd operates under a structured, process-driven quality management system focused on consistency and continual improvement. It provides assurance that our organizational controls, documentation, and performance monitoring support reliable operations and consistent quality, giving customers and partners confidence in our reliability.
Certifcate Registration No: 38125Q00489R053.
Registered Address: Rooms 1209 and 1210, No. 266 Kefeng Road, Lianhe StreetHuangpu District, Guangzhou City, Guangdong Provice, China
Our ISO-certified repair service processes deliver the confidence that regulated healthcare environments require — combining controlled, precise repair with internationally recognized quality systems. Whether supporting clinical use, distribution, or regulatory compliance needs, Guangzhou Rongtao Medical Technology Co., Ltd ensures every service and repaired part is performed under standards you can trust.
Certification Documents (ISO 13485:2016 / ISO 9001:2015)
For compliance and regulatory security, certification documents are provided directly to verified business and regulatory contacts. Please complete the brief request form below.
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