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Medical Device and Diagnostic Solutions

连接的见解。专家交付。对于产品生命周期的每个阶段。

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ISO 14155:2011

欧盟MDR和IVDR实施和截止日期 - 欧盟MDR申请延迟的提案

In this booklet, you will find requirements described in the ISO 14155:2011. The ISO 14155:2011 defines requirements to protect the rights, safety and well-being of human subjects; to ensure that the results of a clinical trial are credible; to confirm the scientific conduct of the clinical study; and to specify the responsibilities of the ethics committees, regulatory authorities and other bodies involved in the clinical trial as well as the responsibilities of the sponsor and the investigators. Compliance with ISO 14155:2011 is an essential contribution to the overall trial success.

Regulatory

你准备好了吗?即将到来的监管要求对组合产品报告的影响

结合产品:它们是什么?任何产品formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.

Brexit.

No-Deal Brexit可能会影响医疗器械开发:法律后果和风险缓解策略

NO-DEAL BREXIT如何影响我的医疗设备生命周期?欧盟和GB国旗在一起助引不确定性环绕着英国迫在眉睫的欧盟出口,可能有可能有“无交易”情景。

Case Study

Avoiding Market Access Delay Due to Incorrect Product Classification Case Study

A startup company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small. But by correctly classifying the device, time to market was minimized.

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150. Device Development Specialists
3. Decades of Device Experience
500 Device Trials in the Past 5 Years

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It is an exciting time for medical device and diagnostic development. Innovations such as AI, robotics, mobile/ home-health, apps and combination products are transforming healthcare. Advances so forward thinking that they are out-pacing today’s regulatory environment.

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“随着药物,设备和诊断发展的深刻体验,以及完整的监管,质量,卫生经济和报销,手术原型,生物相容性测试和临床试验,教育和患者安全服务,景气是独特的,以帮助您实现这一目标您的产品的全部潜力。“

-suzanne carroll.
Vice President, Covance Medical Device and Diagnostics

Covance Insights

Integrated Medical Device and Diagnostics Solutions
Integrated Medical Device and Diagnostics Solutions
信息表
无论您是如何开发医疗设备还是体外诊断产品,您现在都可以通过市场支持,从概念中汇集开发旅程的创新方法。一个凝聚力的模型,使您能够获得满足您所有利益相关者所需的答案 - 投资者,监管机构,付款人,提供商和患者。由专业的医疗设备和诊断解决方案集团致敬的粘性解决方案,Labcorp的合同研究组织(CRO)。
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实验手术和外科医疗器械开发的虚拟巡回课
实验手术和外科医疗器械开发的虚拟巡回课
Videos & WebinarsPlay Video
专为实验手术和培训而设计了我们的AAALAC认可的研究设施的虚拟之旅,以支持医疗器械开发。四个或外科套房和适用于型套房,可容纳大型小组,位于旧金山湾区。
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你准备好了吗?即将到来的监管要求对组合产品报告的影响
你准备好了吗?即将到来的监管要求对组合产品报告的影响
博客s
结合产品:它们是什么?任何产品formed from the combination of a drug, a device and a biologic is referred to as a combination product. Under 21 CFR 3.2 (e) this includes two or more regulated components that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
阅读更多
调查人员的小顾问 -  ISO 141亚博全站官网55:2011医疗器械试验
调查人员的小顾问 - ISO 141亚博全站官网55:2011医疗器械试验
小册子
In this booklet, you will find requirements described in the ISO 14155:2011. The ISO 14155:2011 defines requirements to protect the rights, safety and well-being of human subjects; to ensure that the results of a clinical trial are credible; to confirm the scientific conduct of the clinical study; and to specify the responsibilities of the ethics committees, regulatory authorities and other bodies involved in the clinical trial as well as the responsibilities of the sponsor and the investigators. Compliance with ISO 14155:2011 is an essential contribution to the overall trial success.
阅读更多

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