Notified Body designation and scope, the impact of Brexit and Competent Authority and Notified Body interpretation of the regulations. Make sure you are up to date!

医疗器械和IVDS的临床评估- MedTech eBook Series

Share this article

单击上面的图像或here探索报告。

虽然欧盟MDR延迟到2021年5月26日,但允许医疗设备,软件和组合产品制造商额外一年,以确保其系统遵守监管要求,Covid-19创建的挑战使得这一复杂的实施更加综合实施。

在这个互动电子书,医学技术峰会达克es an in-depth look at how the EU MDR will affect clinical evaluations for medical devices and IVDs in numerous ways, making the regulation more stringent. Industry experts offer insights on Clinical Evaluation Reports (CERs), “sufficient clinical evidence”, Post-market clinical follow-up (PMCF) and much more, including:

  • 欧盟设备和诊断监管前景至5月2011年:Medtech在这些前所未有的时期,Medtech能够在2020年的剩余时间内预期到2021年的上半场?Medtech Insight探索。
  • EU Post-Market Clinical Follow Up: What Manufacturers Need To Know:In this interview, Sarah Sorrel, a leading EU expert and consultant on clinical data issues, discusses with Medtech Insight what post-market clinical follow-up will entail.
  • Differences in Clinical Evaluations and Investigations under the EU MDR:本白皮书评估欧盟MDR下的临床评估和调查的新期望。
  • 行业声音:为欧盟MDR临床改变做准备:我们与峡谷的罗勒AKRA,Zhiquique,临床评估经理,临床评估经理,临床操作临床经理,关于工程师的临床行动,了解如何为欧盟MDR临床变化做准备。

单击页面顶部的图像或here探索报告。

Share this article