On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the rules for in vitro diagnostic
A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional Radiology, offers a detailed analysis
We’re excited to welcome Jorrit Boersen to the MedQAIR team as our newest Consultant. With a strong background in Technical Medicine and a focus on
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel like a maze—complex, time-consuming, and
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside Lara Rashdan from hema.to. In
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated medical device landscape of the
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
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