EU MDR & IVDR Insider September 2025 Issue A free publication from AKRA TEAM UPDATE Welcome to the September Issue of EU MDR & IVDR InsiderUpdate by Bassil Akra, PhD INSIGHTS - CAPA Fundamentals: From Compliance to Prevention with Anna Spehl — AKRA TEAM - 9 CAPA Essentials Reviewers Expect wit...

The July Issue of EU MDR & IVDR Insider Is Here Fresh insights and resources for Medical Device and IVD Manufacturers This issue covers strategic guidance on global audit alignment through MDSAP, with a special focus on Software as Medical Device (SaMD) and the evolving harmonization landscape. ...

  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 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...