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三月 08, 2022

Qserve supports you in supporting the Ukraine

Our feelings, prayers and our support are for all Ukrainians who are fighting for their right to exist.

Medical Devices Ukraine Highlights

三月 03, 2022

FDA提案修订21 CFR第820部分，对齐ISO 13485:2016

2022年2月23日，FDA公布了其关于修订21 CFR第820部分质量体系法规的提案。这项新提案旨在调整和协调当前的医疗器械法规21 CFR 820和ISO 13485:2016。

FDA ISO 13485:2016 Highlights

结果

五月 26, 2022

Wake up to the IVDR! Today, the 26th of May, is the 'Date of Application', the date the new IVDR goes live

Wake up to the IVDR! Today, the 26th of May is the “Date of Application”, the date the new IVDR goes live. Many describe this as a cultural shift as it does not just change the regulation but in many cases the way we do business. It will impact all IVDs on the EU market and the associated supply chain.

Europe In-Vitro Diagnostics IVDR MDCG

五月 24, 2022

Wouter Mattheussens joins Qserve

Wouter Mattheussens has joined Qserve Group where he is part of the Qserve CRO team and works as a Clinical Project Manager.

CRO GCP ISO 14155

五月 17, 2022

Saskia Schoenmakers joins Qserve

Saskia Schoenmakers has joined Qserve Group as a consultant where she is part of the IVD team. With her experience in IVD product development, technical documentation and technical & application support, she will make a valuable contribution to our global customers.

FDA In-Vitro Diagnostics ISO 13485:2016 IVDR Technical Documentation

五月 13, 2022

世界很小，差异很大

让我们放眼看看欧洲中等规模的医疗器械制造商，他们有些刚刚成功获得CE证书并准备开拓新的市场——美国、加拿大、巴西、中国、韩国等。QMS体系通常已根据ISO 13485标准进行认证，似乎在注册途径上不应该有任何其他障碍。

MDSAP Medical Device Regulations

五月 09, 2022

MDCG 2022-5和“可能作用于人体”的概念 - 小题大作？

关于医疗器械和医药产品边界指南最终版本现已发布。它的发布备受欢迎，因其取代了仅适用于MDD，但实际上由于缺乏替代指南，曾仍被用于解决复杂MDR产品分类问题的旧版“边界手册”。

MDCG Medical Device Regulations

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