Tag: Economic Operators

September 17, 2025

At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of

September 9, 2025

At MedQAIR, we combine regulatory expertise with a passion for building bridges, connecting continents, linking innovators with compliance, and uniting

August 13, 2025

Navigating post-market compliance under MDR/IVDR has never been more complex. As regulatory demands rise, responsibility no longer rests solely with

August 1, 2025

Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers

July 22, 2025

Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are

June 24, 2025

On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the

June 18, 2025

A new paper titled “The AI Act: responsibilities and obligations for healthcare professionals and organizations,” published in Diagnostic and Interventional

June 10, 2025

We’re excited to welcome Jorrit Boersen to the MedQAIR team as our newest Consultant. With a strong background in Technical

April 8, 2025

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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