June 10, 2025
Meet the Team: Jorrit Boersen
We’re excited to welcome Jorrit Boersen to the MedQAIR team as our newest Consultant. With a strong background in Technical
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May 20, 2025
European Commission Releases Updated MIR Form 7.3.1
On May 5, 2025, the European Commission published version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with accompanying
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May 8, 2025
Team-NB Releases Updated Best Practice Guidance on MDR Technical Documentation
Team-NB, the European Association of Medical Devices Notified Bodies, has published Version 3 of its “Best Practice Guidance for the
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May 7, 2025
EU Medical Device Notified Bodies Update Position on AI Act Implementation
Team-NB, the European Association for Medical Devices of Notified Bodies, has released an updated position paper addressing the implementation and
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April 8, 2025
Meet the Team: Willibrord Driessen
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving,
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March 25, 2025
Meet the Founders #2: Leon Doorn
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry is ever-evolving,
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March 14, 2025
Upcoming Revision of ISO 10993-1: Key Changes for Medical Device Manufacturers
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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March 10, 2025
European Health Data Space (EHDS) Regulation Published
The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March
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March 4, 2025
Meet the Founders #1: Ivo Flipse
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel
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