Preclinical & Experimental Surgery Solutions

验证原型的安全性和性能

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Comprehensive biocompatibility tests

最先进的外科手术或套房

Training locations and resources

开始一段旅程设计下一个医学device breakthrough brings new considerations in the preclinical stage of development, such as:

  • Are the materials being considered safe and biologically compatible?
  • Does an implantable device prototype fit and work the way we intended?
  • 我如何最好地培训我的商业团队和医生?

Craft the optimal preclinical strategy by collaborating 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:


Biocompatibility Testing

证明您的设备由生物兼容材料制成,是每个设备的监管要求。从一个实心计划开始,该计划识别您的特定设备的正确生物相容性研究,然后在我们的EN 45011,ISO 17025,GLP或GMP认证的全球实验室中前进,提供高质量的科学数据和分析支持。您的定制测试路线图可确保您获得将设备进入下一个开发阶段所需的数据,快速有效地。

Access a full range of biocompatibility testing in the following critical categories:

  • 急性全身毒性
  • 生物相容性/风险评估报告
  • 致癌性
  • Chemical assays (fingerprint assays and extractable & leachable testing)
  • Cytotoxicity
  • Developmental and reproductive toxicity
  • Genotoxicity
  • 血液相位性
  • Implantation (local effects and toxicity studies)
  • 体外刺激
  • In vivo irritation
  • 物质介导的热原性
  • Sensitization
  • Sub-acute, sub-chronic and chronic toxicity

Experimental Study Solutions

Sometimes you need more information to optimize your product concept to get to your final prototype. Gain valuable insight with an early surgical test using a built-for-purpose operating room (OR). An experimental study will provide you with a better understanding of how you can enhance your design or develop your concept further.

Access four surgical OR suites that are fully equipped for your experimental surgery requirements. Start with guidance on selecting the right high-quality surgical models that meet exacting scientific and regulatory standards. Plus, enjoy full support, including model and OR preparation, necropsy and pathology support, surgery scrub, instrument preparation and laboratory tests, and even an engineering lab should your device require minor adjustments during testing.

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:

  • Cardiovascular
  • Dental
  • 药物递送
  • 胃肠道
  • Neurologic
  • Ophthalmology
  • Orthopedic
  • 组织工程
  • Urogenital
  • Neurologic
  • Wound healing

伙伴with our highly skilled veterinary team to choose the appropriate model and implement your study design under GLP or non-GLP standards, ensuring you get the information you need to progress your proof of concept.

  • GLP: Conduct your GLP study under acute or chronic research protocols. Work closely with a program manager throughout the testing process, including protocol development and model selection, in-life phase, and authoring the final study report for regulatory submission.
  • Non-GLP: Not every study requires the rigor of a GLP study. For exploratory research, non-GLP testing is an affordable approach to get quick decision-making insight to inform your early design. Your study is still performed under conditions similar to GLP and optional report and pathology are available upon request.

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.

You have access to imaging equipment for documenting the placement and performance of your implanted device.

  • Cardiac catheterization lab
  • Fluoroscopy
  • General ultrasound
  • ICE (intracardiac echocardiography)
  • IVUS(血管内超声)
  • 腹腔镜塔
  • TEE (transesophageal ultrasound)
  • Transthoracic ultrasound

Education 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).

With access to our 22,000 square foot facility, four spacious surgical suites and a synergy of tools, providing your team with the best learning environment to achieve your training objectives is a whole lot easier. Your trainers can share techniques that provide your medical professionals with the level of expertise needed to ensure success.

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.
  • Cadaver-based training
  • 临床培训
  • Clinical trial investigator training
  • 教学培训
  • Educational programs
  • Hands-on workshops
  • Nonclinical model-based training
  • Product launches
  • 研发市场调查和产品评估
  • Sponsor-designed, product-specific instructional courses
  • Surgeon-to-surgeon training
  • 研讨会

更大群体的培训选择

使用最先进的音频/可视化设备培训更大的群体,可提供多个摄像头视图,并从每个或套房展示入场,进入位于邻近的观看室。

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
  • Four state-of-the-art surgical OR suites
  • Access to imaging equipment for viewing surgical results
  • Audio/visual capabilities for onsite viewing by larger groups
  • General surgical support team
  • 集团学习会议,网络和膳食休息的邻近空间
  • Catering support coordination

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