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
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,
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated
As an Authorised Representative (AR) in the European Union (EU), the role encompasses critical responsibilities regarding the management of manufacturer
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