On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the
A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional
We’re excited to welcome Jorrit Boersen to the MedQAIR team as our newest Consultant. With a strong background in Technical
On May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying
Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the
Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving,
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving,
The International Organization for Standardization (ISO) is preparing a revision of ISO 10993-1, the critical standard governing the biological evaluation
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