The June Issue of EU MDR & IVDR Insider Is Here Fresh insights and resources for Medical Device and IVD manufacturers This issue covers essential guidance on mastering medical literature review with a focus on notified bodies, R&D, and systems that scale. [Download the Full PDF issue] What’s I...

The April Issue of EU MDR & IVDR Insider Is Here Providing expert insights and practical resources for medical device and IVD manufacturers. This issue covers essential guidance on post-market surveillance (PMS), vigilance reporting, and the implications of updated UK regulations. [Download the ...

  The Second Issue of EU MDR & IVDR Insider is Here Providing expert insights and practical resources for medical device and IVD manufacturers. This issue covers the latest updates on orphan devices, critical regulatory changes, and a major initiative that could transform clinical trials in the ...

The inaugural issue of EU MDR & IVDR Insider is here, providing practical resources and expert guidance for medical device and IVD manufacturers. This issue highlights Article 10a compliance ahead of the January 10, 2025, deadline and offers insights into regulatory requirements for orphan devic...