Certifications & Compliance

Certified for Safety, Trusted by Professionals

Why ISO Certification Is Essential in Medical Device Manufacturing

ISO certification isn’t just a formal requirement — it’s the foundation of trust, safety, and consistency in medical products.

For healthcare partners and institutions, ISO certification means:

A quality management system built specifically for medical devices (ISO 13485:2016)
Consistent product 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 design and manufacturing to inspection 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 medical product we manufacture is developed and produced under FDA-aligned quality systems and ISO 13485:2016 and ISO 9001:2015 certified processes. Hospitals, distributors, and regulatory partners choose RT Medical because our operations emphasize controlled manufacturing, documented compliance, and consistent product quality — 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 design, manufacturing, risk management, and traceability — providing confidence that every product is produced 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 medical manufacturing processes deliver the confidence that regulated healthcare environments require — combining controlled production with internationally recognized quality systems. Whether supporting clinical use, distribution, or regulatory submission, Guangzhou Rongtao Medical Technology Co., Ltd ensures every product is manufactured 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.