Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a new pathway for Class III
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are distributed across various economic operators
On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a pivotal final rule reclassifying radiological computer-assisted detection and diagnosis (CADe/CADx) software from
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
Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the Submission of Technical Documentation under
Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and application of the EU Artificial
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
The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March 2025 and will enter into
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