江蘇博賽孚醫(yī)療科技有限公司
博賽孚醫(yī)療是以驗(yàn)證醫(yī)療器械、生物材料、藥物和藥械組合產(chǎn)品生物相容性及功效性評價(jià)的臨床前?CRO綜合性服務(wù)平臺(tái)。
公司位于蘇州常熟市高新區(qū)，以打造國際標(biāo)準(zhǔn)化醫(yī)療器械臨床前評價(jià)中心為目標(biāo)，總面積4114?m2，其中動(dòng)物實(shí)驗(yàn)中心2000?m2、檢測中心500m2和醫(yī)生培訓(xùn)中心500?m2。
公司擁有FDA?GLP聲明型資質(zhì)和CNAS-CLO1實(shí)驗(yàn)室認(rèn)可資質(zhì)。核心團(tuán)隊(duì)擁有豐富的GLP?管理體系運(yùn)行經(jīng)驗(yàn)，同時(shí)也是美國FDA認(rèn)可的醫(yī)療器械臨床前評價(jià)毒理和病理學(xué)報(bào)告資質(zhì)的中國團(tuán)隊(duì)。
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.