Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are
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
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