Function and Safety Evaluation

Preclinical animal experimental research on medical devices

The Center boasts the facilities necessary for raising large experimental animals and primates. It is equipped with state-of-the-art global equipment and led by a professional research team, headed by internationally renowned doctors. The center specializes in various medical fields including neurosurgery, orthopedics, cardiovascular, respiratory, digestive, gynecological, urology, surgery, ophthalmology, otorhinolaryngology, dentistry, and more. Its range of services encompasses medical device treatment efficacy assessment, indicator research, safety evaluation research, and preclinical experimental research. The center collaborates closely with domestic and foreign regulatory authorities, industry-leading enterprises, and top-tier hospitals to offer expert technical support.

Biocompatibility Test

We operate with independent barrier-level housing rooms and laboratories, as well as separate common-level housing rooms and laboratories. Additionally, we maintain specialized sterile testing rooms, microbiological identification rooms, and P2 level microbiological laboratories. Our testing arsenal comprises multi-channel pyrogen thermometers, Olympus fluorescence microscopes, Meryella identification machines, Millipore membrane filtration systems, Pyros Kinetix bacterial endotoxin testers, and various other equipment. These tools enable us to conduct a wide range of tests, including toxicology, genetics, immunology, sterility performance, and microbial limits assessment on medical devices. Our business scope encompasses biological safety evaluation of medical devices, microbiological experimental research, disinfection control, and validation, among other services.

In house hematology and serum chemical analysis and material analysis texting

Pathological examination of blood, body fluids, tissue, and characterization analysis of medical materials

The Analysis and Testing Department comprises a clinical laboratory and a material analysis and testing laboratory. Our facilities include full-process pathological equipment, blood and fluid examination tools, and chemical analysis instrumentation, empowering us with the capability to analyze both soft and hard tissue pathology. Clinical testing encompasses pathological examination, analysis of bodily fluids, and more. Material analysis testing involves characterizing material chemistry, analyzing leachable substances, and assessing drug compatibility.

Training,Education,Promotion,and Academic Exchanges on Novel Medical Device

With efficient professional service capabilities, extensive senior solution experience, and a wealth of project service experience, we uphold the highest industry standards and quality requirements. Our commitment is to provide a full-cycle service chain for clinical research tailored to various product mechanisms and clinical application scenarios. Drawing upon the unique characteristics of each product, we plan the optimal registration solution and deliver a a full cycle service chain for product registration.

Clinical Research(CRO) and Regulatory Consulting Services

As a comprehensive training center, we offer a diverse array of training facilities, including a comprehensive and multi-scenario training room equipped with large-scale medical equipment such as implanted interventional medical devices, surgical robots, innovative medical devices, and new technologies for preclinical use. Our center provides education and training sessions, surgical demonstrations, and practical services such as live broadcasts of manual surgeries, all aimed at delivering systematic medical training guidance. Furthermore, as an open service center, we feature education and training operating rooms alongside video training classrooms. These facilities enable us to deliver refined education and training services.