江苏博赛孚医疗科技有限公司
博赛孚医疗是以验证医疗器械、生物材料、药物和药械组合产品生物相容性及功效性评价的临床前 CRO综合性服务平台。
公司位于苏州常熟市高新区,以打造国际标准化医疗器械临床前评价中心为目标,总面积4114 m²,其中动物实验中心2000 m²、检测中心500m²和医生培训中心500 m²。
公司拥有FDA GLP声明型资质和CNAS-CLO1实验室认可资质。核心团队拥有丰富的GLP 管理体系运行经验,同时也是美国FDA认可的医疗器械临床前评价毒理和病理学报告资质的中国团队。
Jiangsu Bio-safety Medical Technology Co., Ltd
Bio-safety Medical is a preclinical CRO comprehensive platform for verifying the biocompatibility and efficacy evaluation of medical devices, biomaterials, drugs and medical equipment combination products.
Located in Changshu High-tech Zone, Suzhou, with the goal of building an international preclinical evaluation center for medical devices, the total area is 4114 square meters, including 2000 square meters of animal experiment center, 500 square meters of testing center and 500 square meters of doctor training center.
Have FDA GLP Declaration Qualification and CNAS-CL01 Laboratory Accreditation Qualification The core team has a rich GLP management system and is also a Chinese team with FDA-approved toxicology and pathology report qualification for preclinical evaluation of medical devices.