yaboapp体育官网临床前与实验外科解决方案

Verify the safety and performance of your prototype

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全面的生物相容性测试

最先进的外科手术或套房

培训地点和资源

Embarking on a journey to design the next medical device breakthrough brings new considerations in the preclinical stage of development, such as:

  • 这些材料被认为是安全和生物学兼容的吗?
  • 植入式设备原型是否适合并按预防方式工作?
  • 我如何最好地培训我的商业团队和医生?

工艺最优collabor临床策略yaboapp体育官网ating with our medical device development specialists. Then access the preclinical resources necessary to make your initial development stage easier. Whether you are exploring a promising device concept, initiating a comprehensive testing plan or conducting a single study, Covance Medical Device and Diagnostic Solutions can help you prove out your device in its earliest stage of development:


生物相容性测试

Proving your device is made of biologically compatible materials is a regulatory requirement of every device. Start with a solid plan that identifies the right biocompatibility studies for your specific device, and then move forward conducting your studies at one of our EN 45011, ISO 17025, GLP or GMP certified global laboratories that deliver high-quality scientific data and analytical support. Your customized testing roadmap ensures you get the data required to progress your device to the next stage of development, quickly and efficiently.

访问以下关键类别中的全系列生物相容性测试:

  • 急性全身毒性
  • 生物相容性/风险评估报告
  • 致癌性
  • 化学assays (fingerprint assays and extractable & leachable testing)
  • 细胞毒性
  • 发育和生殖毒性
  • 基因毒性
  • 血液相位性
  • 植入(局部效应和毒性研究)
  • In vitro irritation
  • 体内刺激
  • 物质介导的热原性
  • 敏感
  • 亚急性,亚慢性和慢性毒性

Experimental Study Solutions

有时您需要更多信息来优化您的产品概念以进入最终的原型。使用内置目的的手术室(或),获得早期手术试验的宝贵洞察。实验研究将使您更好地了解如何增强您的设计或进一步发展您的概念。

进入四种手术或套房,该外科设备或套件完全配备了您的实验手术要求。从指导开始,了解符合严格的科学和监管标准的正确高质量的外科手术模型。此外,享受全面的支持,包括模型和或准备,尸检和病理支持,手术磨砂,仪器准备和实验室测试,甚至您的设备应在测试期间需要进行微小的调整。

确定最适合您的学习需求的适当模型不一定是挑战。与我们的团队合作以评估和开发动物模型系统,或为各种设备类型选择合适的人类解剖模型,包括:

  • 心血管
  • Dental
  • 药物递送
  • Gastrointestinal
  • Neurologic
  • 眼科
  • 骨科
  • 组织工程
  • Urogenital
  • Neurologic
  • 伤口愈合

与我们高技能的兽医团队合作,选择适当的模型,并在GLP或非GLP标准下实施您的学习设计,确保您获取所需的信息,以前取得概念证明。

  • GLP.:在急性或慢性研究方案下进行GLP研究。在整个测试过程中与计划经理密切合作,包括协议开发和模型选择,生活中的阶段,并为监管提交的最终研究报告编写。
  • Non-GLP:并非每项研究都不需要RGP研究。对于探索性研究,非GLP测试是一种经济实惠的方法,可以快速决策洞察,以告知您的早期设计。您的研究仍然在类似于GLP的条件下进行,并且可根据要求提供可选的报告和病理学。

尸体研究make it easier to assess the function of your device within the human body, potentially with more accuracy. Gain valuable experience visualizing your device in conjunction with the bones, muscles and organs that it ultimately will come into contact with in the living body. Full cadavers, partial cadavers and/or relevant tissues are available to support your study to exacting specifications, via approved vendors, while reducing the number of non-human models required for research.

您可以访问成像设备,以记录植入设备的放置和性能。

  • 心脏导管插座实验室
  • 透视
  • 一般超声波
  • ICE (intracardiac echocardiography)
  • IVUS(血管内超声)
  • Laparoscopic towers
  • TEE(TranseSophageL超声)
  • Transthoracic ultrasound

教育and Training Resources

Advance your sales team’s marketing efforts and investigator skills with hands-on clinical education to build knowledge or skills related to your medical device - using non-human and human anatomical models (tissue or cadavers).

通过访问我们的22,000平方英尺的设施,四个宽敞的外科套房和工具的协同作用,为您的团队提供最佳学习环境,以实现您的培训目标是一个容易的大量。您的培训师可以分享提供您的医疗专业人员的技术,以确保成功所需的专业知识。

The Covance Medical Device and Diagnostic Solutions education site gives you access to an integrated training space that flexes to your curriculum. Start with an engaging didactic session, move into the OR for hands-on surgical training and end with a feedback or Q&A session. It’s all possible at one site for a full range of training programs:

  • BioSkills Labs.
  • 基于尸体的培训
  • 临床培训
  • 临床试验员培训
  • 教学培训
  • 教育al programs
  • Hands-on workshops
  • 非临床模型的培训
  • 产品推出
  • 研发市场调查和产品评估
  • Sponsor-designed, product-specific instructional courses
  • Surgeon-to-surgeon training
  • Symposia

更大群体的培训选择

Train larger groups using state-of-the-art audio/visual equipment that provides multiple camera views and display options from each of the OR suites into onsite adjacent viewing rooms.

位置便利,装满学员的设施

  • 距离旧金山国际(SFO)机场有15分钟路程
  • 四个最先进的外科手术或套房
  • 访问成像设备以查看手术结果
  • Audio/visual capabilities for onsite viewing by larger groups
  • 一般外科支持团队
  • Adjacent space for group learning sessions, networking and meal breaks
  • Catering support coordination

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