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十一月 16, 2022

Qserve Group joins Alpe d'HuZes 2023

As a healthcare company, we are proud to support our team in joining the Alpe d’HuZes event to raise funding for cancer research

Alpe d'HuZes Cancer research Fundraiser Highlights

九月 27, 2022

基本性能和单一故障| 灰色问题脑力训练！第2期

你最近拥抱过一个细心的人吗？我们都很感激那些有条不紊完成复杂工作的人们的成果，尽管常常认为这是自然而然的。美术、精美建筑、稳健可靠的技术、航空科技和脑外科手术，这些都是人们脑海中会花时间检查每一个细项而不做任何假设的例子。我们中的一些人有这种“天赋”，而另一些人需要学习，还有一些人则需要被强迫。医疗器械法规和标准并不关心开发商/制造商属于哪一类细节导向，因为在合规性方面，所有人都必须达到最低水准。单一故障分析就是一个很好的例子。

IEC 60601-1 Medical Devices Highlights

结果

一月 31, 2023

Free Webinar PDF Download | Medical Device Sterilization – Addressing EPA’s Clean Air Act

Medical Device Regulations

一月 31, 2023

On-Demand Webinar | Medical Device Sterilization – Addressing EPA’s Clean Air Act

Medical Device Regulations On-Demand Webinar Highlights

一月 31, 2023

Proposed Extension of Transition Period of the MDR: Don’t Take Your Foot off the Gas!

Before you go on reading, keep in mind nothing is set in stone yet. The proposal still needs to be adopted by the European Parliament and the Council through an accelerated co-decision procedure.

MDR 2017/745 Highlights

一月 18, 2023

Basic Safety Standards 60601 vs. 61010-1

Do you know the difference between safety standards 60601-1 vs 61010-1 in medical devices and in vitro diagnostics? Find out ways to differentiate these safety standards and learn more in his newly released blog, Basic Safety Standards 60601 vs. 61010-1, It's Almost Binary.

Medical Device Regulations 60601 61010-1 Highlights

一月 12, 2023

MDCG PSUR新指南| 对IVD制造商有何意义？

就在年底前，医疗器械协调小组（MDCG）根据条例（EU）2017/745（MDR）发布了一份关于定期安全更新报告（PSUR）的新指南文件（MDCG-2022-21）。PSUR是欧盟对高风险医疗器械和体外诊断医疗器械（IVD）的新要求之一。

In-Vitro Diagnostics IVDR MDCG PSUR PMPF Highlights

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