澎立检测是独立的第三方医疗器械检测临床前动物实验一站式服务平台,是全国首家医疗器械领域获得CNAS认证的第三方大动物实验中心。技术团队主要实验人员均具有10年以上医疗器械行业工作经验。现有设备:通用 IGS330 DSA,飞利浦 EPIQ7C 四维超声,西门子心腔内超声ICE;OCT系统;骨科小型C臂机等;拥有超过4500平方米的标准动物饲养区:配备多功能手术区,可同时开展介入手术,无菌植入手术及急性培训手术。服务包括:动物实验方案设计与法规咨询、产品可行性分析与验证设计、临床前动物实验测试与研究、病理学及药代动力学分析研究、临床申报和注册申报支持、医师培训服务、上市推广支持服务。
PharmaLegacy Diagnostic Laboratories (Shanghai) Co., Ltd. is a pre-clinical large animal experiment facility. PharmaLegacy Diagnostics focus on high-risk medical device testing in preclinical area, and provide one-stop services. The operation follows international GLP regulations/guidelines, AAALAC standards. PharmaLegacy Diagnostics has filed China National Accreditation Service for Conformity Assessment and got the certification, No.: CNAS LA0011..
PharmaLegacy Diagnostics focus on the preclinical animal tests, including study protocol design, related regulatory consultation, animal experiment tests, pathology /pharmacokinetic analysis, and pre-market support. Scopes cover cardiovascular, intracranial, osseous/dental degradable implants, active implantable medical devices, and drug delivery systems, etc.