Shandong Xinbo Pharmaceutical Research Co., Ltd. (hereinafter referred to as "the Company") was established in April 2010. It is a national high-tech enterprise and a Shandong Provincial Enterprise Technology Center. Its business scope covers pharmacological research, toxicology research, drug analysis and testing, animal pathology testing, and medical device evaluation.

Since its establishment, the company has carried out biological evaluation of medical devices in accordance with GLP regulations, and has completed nearly a hundred related evaluation projects, covering 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 material (drug containing instrument), calcium silicon bioceramic bone, absorbable hemostatic fluid gelatin, degradable ear and nose hemostatic sponge, biological amniotic villus membrane, absorbable hemostatic gauze, dura mater sealing adhesive, disposable high-frequency cutting knife and other varieties. In addition to the biological evaluation tests involved in the GB/T 16886 series standards, the company has also conducted corresponding animal experiments based on the characteristics of various instruments to evaluate their safety, effectiveness, and feasibility.

The company has invested in the establishment of a Medical Device Safety Evaluation Research Center in recent years and officially put it into use in 2022. The center has a total construction area of approximately 6000 square meters and is equipped with functional areas such as large animal laboratory, animal operating room, functional laboratory, barrier animal laboratory, small animal laboratory, and dissection room. It is equipped with CT, DR (digital X-ray photography system), veterinary ultrasound diagnostic instrument, animal respiratory anesthesia machine, monitor, high-frequency electric knife, oxygen generator, rat brain locator, sterilization equipment, 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 and other instruments and equipment. More than 700 units (sets).


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