Shandong Xinbo Pharmaceutical Research Co., Ltd. was established in April 2010. It is a national high-tech enterprise and a Shandong Provincial Enterprise Technology Center. It is the only scientific research service-oriented enterprise in the province that integrates pharmacological research, toxicology research, drug analysis and testing services, animal pathology testing, and medical device evaluation services.

Since its establishment, Shandong Xinbo has been actively conducting biological evaluations of medical devices and has completed nearly a hundred evaluation projects in accordance with GLP requirements, such as absorbable dura mater sealing medical adhesive, absorbable vascular sealing medical adhesive, alpha cyanoacrylate medical adhesive, injectable root filling paste, disposable absorbable nail intradermal stapler, needle free injector, active biological bone repair materials (drug containing devices), calcium silicon bioceramic bone, absorbable hemostatic fluid gelatin, degradable ear and nose hemostatic sponge, biological amniotic membrane chorion, absorbable hemostatic gauze, dura mater sealing adhesive, disposable high-frequency cutting knife, etc. In addition to conducting experiments on the biological evaluation of medical devices according to GB/T 16886, Multiple animal experiments on medical devices were conducted based on the characteristics of each device (excluding biocompatibility experiments not covered in the GB/T16886 series standards) to evaluate the safety, effectiveness, and feasibility of medical devices.

In recent years, Shandong Xinbo invested 50 million yuan to establish the Medical Device Safety Evaluation Research Center, which was officially put into use in 2022. The Medical Device Safety Evaluation Research Center has a total construction area of 6000 square meters, mainly including a large animal laboratory, animal operating room, functional laboratory, barrier animal laboratory, small animal laboratory, and dissection room. It purchases CT, pet DR, veterinary ultrasound diagnostic instrument, animal respiratory anesthesia machine, monitor, high-frequency electric knife, oxygen generator, rat brain locator, electric sterilization pot, card type steam sterilizer, ozone disinfection cabinet, binocular indirect ophthalmoscope, slit lamp microscope, biosafety cabinet, biochemical incubator, carbon dioxide incubator, flow cytometer, PCR gene amplifier, fluorescence quantitative PCR instrument, ultra micro ultraviolet spectrophotometer, fully automatic blood biochemistry analyzer, fully automatic blood analyzer, coagulation analyzer, high-performance liquid chromatography, mass spectrometer. There are a total of 748 sets of instruments waiting.





Medical device service project:

In vitro cytotoxicity test

Whole body toxicity test

Local reaction test after implantation

Stimulus and delayed type hypersensitivity test

Genetic toxicity test

Reproductive toxicity test

Preclinical animal safety and efficacy testing of medical devices

Non clinical animal trials of drug device combination projects