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Medical Device and Diagnostic Solutions

融会贯通的见解,专家级交付水准。针对产品生命周期的每个阶段。

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欧盟MDR和IVDR的实施及期限——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.

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您是否做好了准备?即将出台的法规要求对于复合产品报告的影响

组合产品:这是什么?由药物、器械和生物制品的组合构成的任何产品称为组合产品。根据21 CFR 3.2 (e),这包括两个或多个受管制的成分,这些成分在物理、化学或其他方面组合或混合并作为单个实体生产。

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无协议脱欧对医疗器材研发有何影响:法律后果和风险缓解策略

无协议脱欧对我的医疗器材的生命周期将有何影响? EU and GB flags togetherConsiderable uncertainty surrounds Britain's imminent exit from the EU, and it is possible that there could be a "no-deal Brexit" scenario.

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避免由于产品分类错误而导致的市场准入延迟案例研究

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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By the Numbers

150

Device Development Specialists

3

Decades of Device Experience

500

Device Trials in the Past 5 Years

Hello Device标识

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Hello Device

对于医疗器材和诊断研发而言,这是一个令人兴奋的时刻。 Innovations such as AI, robotics, mobile/ home-health, apps and combination products are transforming healthcare. 如此超前的思维造成当今的监管环境已无法跟上其步伐。

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“With deep experience of drug, device and diagnostic development, and a complete suite of regulatory, quality, health economics & reimbursement, surgical prototyping, biocompatibility testing and clinical trials, education and patient safety services, Covance is uniquely positioned to help you realize the full potential of your product.”

Suzanne Carroll
Vice President, Covance Medical Device and Diagnostics

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