Dongdian Medical Accelerates Innovation in MedTech with Integrated One-Stop Device Translation Platform

Medical devices are a heavily regulated sector. From R&D to market launch, devices typically undergo multiple stages—including testing and inspection, animal studies, clinical trials, and regulatory submission—to repeatedly verify their safety, efficacy, and compliance, particularly for first-of-their-kind Class III innovative medical devices. Meanwhile, the medical device industry is a highly competitive arena, where every second counts in animal studies, clinical trials, and regulatory approval. Third-party medical device translation services have pressed the “accelerator button” for the commercialization of innovative devices.

With ongoing innovation in medical devices and the gradual improvement of national registration and review regulations, third-party medical device translation services are evolving toward greater specialization and one-stop solutions.One-stop medical device translation services not only improve service quality and accelerate the conversion of innovative devices, but also reduce communication costs, enabling efficient and high-quality transformation of innovative medical devices.

Dongdian Medicine, based in Hangzhou, provides one-stop medical device translation services, covering the entire process including device testing and inspection, large animal studies, human clinical trials, registration, and training on new medical technologies.Dongdian Medicine’s two sister companies—Comed, in the field of clinical research for medical devices, and Xidian Kechuang, in preclinical large-animal studies—have both established benchmark positions. Leveraging this foundation, the company possesses extensive project experience and client resources, enabling it to provide customized and professional medical device translation services to domestic and international medical device enterprises.

At the hardware level, Dongdian Medicine occupies a total area of 10,000 square meters, including a 3,000-square-meter experimental surgical area and a 6,000-square-meter animal housing area. It features globally leading interventional catheterization, general surgery, and ophthalmology operating rooms, equipped with cutting-edge inspection, testing, surgical, and imaging devices from world-renowned manufacturers such as Philips, Zeiss, Alcon, and Leica, ensuring comprehensive hardware facilities. In terms of service management quality, Dongdian Medicine adheres to international standards; for instance, its Large Animal Experimental Center is designed and constructed in accordance with AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) standards and follows Good Laboratory Practice (GLP) principles, with standardized internal service processes.

Dongdian Medical provides one-stop medical device translation services, including functional and safety evaluation of medical devices in large animal studies, biological evaluation of medical devices, animal laboratory medicine and material analysis testing, clinical research and registration consulting, as well as training and exchange on new medical technologies., with business scope covering cardiovascular and peripheral interventional devices, active medical devices, surgical robots, tumor ablation systems, and other fields.

This conclusion addresses whether a medical device is relatively safe for future human use or currently acceptable, representing a critical step prior to entering clinical trials. With the release of the new Regulations on the Supervision and Administration of Medical Devices, medical device test reports may be provided either by the medical device registration applicants or filers, or by qualified third-party medical device testing institutions. Dongdian Medicine holds various professional qualifications and offers specialized medical device testing services across multiple fields.

Dongdian Medical features independent barrier-grade animal housing and laboratory facilities, as well as conventional-grade animal housing and laboratories. It also houses specialized sterile testing rooms, a microbial identification laboratory, and a Biosafety Level 2 (BSL-2) microbiology laboratory. Equipped with advanced instruments such as multi-channel pyrogen temperature monitors, Olympus fluorescence microscopes, bioMérieux bacterial identification systems, Millipore membrane filtration systems, and Pyros Kinetix bacterial endotoxin testers, the facility is capable of conducting toxicological, genetic, immunological, sterility, and microbial limit tests for medical devices.

Dongdian Medicine is committed to creating standardized animal experiment processes,The company has established a laboratory quality management system in accordance with GLP and AAALAC guidelines, as well as the ISO/IEC 17025 standard. It has currently obtained the Laboratory Animal Use License and ISO 9001 certification.. The company’s Animal Experiment Center is equipped with facilities for housing large animals and primates, along with globally advanced equipment. Led by internationally renowned experts in animal experimentation, the center conducts research to verify the safety and partial efficacy of medical devices across multiple fields, including neurosurgery, orthopedics, cardiology, respiratory medicine, gastroenterology, gynecology, urology, general surgery, ophthalmology, otolaryngology, and dentistry. This supports timely design adjustments of devices and facilitates more efficient human clinical trials.

Dongdian Medicine can customize full-cycle clinical research services based on the mechanism of action and application scenarios of device products, helping clients plan clinical trial strategies and pathways.Provides CRO services including clinical protocol design and writing, monitoring, CEC and DSMB, data management and statistical analysis, EDC and randomization or registry system development, medical writing, and third-party audits.. During the registration phase, building on its prior services, Dongdian Medical can devise the optimal regulatory pathway tailored to product characteristics, thereby accelerating the acquisition of device certifications.

The promotion of innovative technologies and products is inseparable from clinical education. As a comprehensive training center, Dongdian Medicine provides training rooms that cater to diverse, multi-scenario needs. Equipped with large-scale medical devices such as implantable and interventional medical instruments and surgical robots, as well as innovative medical devices and new technologies for pre-clinical use, the center offers services including educational training, surgical demonstrations, and live broadcasting of surgeries, thereby achieving systematic medical training and guidance.

As an open-service center, Dongdian Medicine is equipped with educational and training operating rooms as well as video training classrooms. The educational and training operating rooms can accommodate up to 10 simultaneous procedures, while the video training conference room can seat 80 people, thereby helping medical device companies conduct systematic and professional training and promoting the large-scale clinical application of medical devices.

Overall, Dongdian Medicine can independently provide services for multiple key stages across the entire medical device translation process. Medical device companies need only hand over their products under development to Dongdian Medicine, and they will not have to worry about the subsequent series of processes.Significantly reduce corporate communication costs and improve conversion efficiency. Meanwhile, Dongdian Medicine can provide higher-quality one-stop services through efficient team collaboration and the accumulation of experience across all stages, thereby strengthening stickiness with medical device enterprise clients.。

Establishing a one-stop platform for medical device translation is no easy feat, with preclinical large-animal studies and clinical trials being two critical and high-barrier stages. Few companies in China possess the capability to provide both services simultaneously; most choose to form partnerships to jointly serve medical device manufacturers. Leveraging the long-term development of its sister companies and the accumulated expertise of its core team, Dongdian Medicine can independently deliver end-to-end services.

CoreMed has been deeply engaged in the medical device CRO sector for over 10 years., provides clinical research services to numerous renowned medical device companies both in China and abroad, and has been included in the global supplier directory of Fortune 500 multinational medical device enterprises. It boasts extensive experience in various fields, including strategic consulting for clinical research on medical devices, clinical trial implementation, imaging core laboratory analysis, and market access.West Point Sci-Tech Innovation is the first large-animal experimental center in western China., has facilitated the entry of multiple medical devices into clinical trials, possessing extensive experience in laboratory animal management, data collection, and overall process control.

The development of the two sister companies has laid the foundation for Dongdian Medicine in terms of technology, service processes, and customer communication.Meanwhile, Dongdian Medical can also collaborate with Comed and Xidian Sci-Tech Innovation to provide medical device clients with end-to-end device commercialization services, covering multiple provinces and cities across China.

Meanwhile, talent is the foundation of Dongdian Medicine.The company’s core team members have devoted decades to preclinical and clinical research in the medical device sector. Having previously held positions at renowned domestic and international medical device manufacturers and third-party service providers, they possess extensive expertise in global large-animal studies, clinical trials, clinical research strategy for products, market access, and regulatory compliance.. The team includes the founder of China’s first large-animal experimental center and pioneers in the field of clinical research, who possess commercialization experience for innovative medical devices at Fortune 500 companies and have helped successfully translate multiple first-of-their-kind devices into practice.

Beyond its robust “internal capabilities,” Dongdian Medicine excels at leveraging “external resources.” The company has established connections with numerous global institutions and experts, medical device CRO firms, and large-animal experimental centers, boasting abundant scientific research and industrial resources.

Internal and external forces have jointly driven the rapid development of Dongdian Medicine. As of now,Dongdian Medical serves over 200 device projects in more than 60 cities across China., including a number of Class III innovative medical devices that are first-of-their-kind in China, and has established high-standard service processes. Meanwhile,Dongdian Medicine’s business scope extends globally. By leveraging overseas resources, it collaborates with renowned international CROs and large-animal testing centers to facilitate the overseas commercialization of Chinese-made medical devices.。

Following the opening ceremony of its innovation center in Hangzhou on the 26th, Dongdian Medical will continue to focus on the field of innovative medical device translation services, providing standardized, professional one-stop translation services for medical device enterprises both domestically and internationally. Meanwhile, the company will continue to develop synergistically with Kemaide and Xidian Sci-Tech Innovation, leveraging the resources of all three parties to serve numerous medical device companies at home and abroad.