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 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 ...