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四月 02, 2024

生物学风险管理在医疗器械开发中的作用

生物学评价是医疗器械符合(EU) 2017/745法规要求的一部分。它始于医疗器械的研发阶段，并贯穿其整个生命周期。相关的系列标准是ISO 10993系列。它提供了实施生物学评价和生物安全性测试要求的应用指南。

Biocompatibility Medical Device Regulations Medical Devices Risk Management

一月 24, 2024

FDA Proposal to Change the Classification of Certain Wound Dressings, Topicals and Liquids

Blog FDA Medical Devices

结果

五月 16, 2024

On-Demand Webinars | Medical Device Registration in worldwide countries

New to our On-Demand webinar series: Canada. Watch our On-Demand webinars to learn more about the regulatory framework in Asia-Pacific, Latin American countries and Canada, presented by our regulatory affairs associates around the world.

ANVISA Argentina Brazil Canada China Colombia Global Registration India Malaysia Market Access China Medical Device Registration Medical Device Regulations Mexico New Zealand NMPA On-Demand Webinar Regulatory Affairs Singapore

四月 30, 2024

确保医疗器械提交的数据真实性：FDA的行动呼吁

FDA Medical Device Regulations Medical Devices

四月 02, 2024

生物学风险管理在医疗器械开发中的作用

生物学评价是医疗器械符合(EU) 2017/745法规要求的一部分。它始于医疗器械的研发阶段，并贯穿其整个生命周期。相关的系列标准是ISO 10993系列。它提供了实施生物学评价和生物安全性测试要求的应用指南。

Biocompatibility Medical Device Regulations Medical Devices Risk Management

三月 18, 2024

Q&A: Chinese Medical Device Regulations NMPA

The most common questions and answers about market access in China. In this whitepaper 21 questions will be answered about the Chinese Medical Device Regulations NMPA. Everything you need to know about Medical Device Registration in China.

China China Agent Global Registration Market Access China Medical Device Registration NMPA Highlights

三月 06, 2024

合规倒计时| 确保欧盟市场准入不足百天

欧盟医疗器械监管条例（EU MDR）截止日期的延长凸显了主动合规的重要性。对于制造商来说，严格遵照时间表递交申请至关重要，因为任何延误都可能对整个监管流程产生连锁反应。及时而全面地提交文件不仅是监管要求，也是确保顺利过渡到合规的关键因素，最终有助于医疗器械行业的整体成功。

Medical Device Regulations Medical Devices Highlights

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