June 10, 2026
Meet the Team: Lauren Perez
At MedQAIR, we know that strong regulatory and quality systems are built on both experience and continuous learning. As medical
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April 6, 2026
Meet the Team: Monique Greijmans
At MedQAIR, we work with professionals who understand that regulatory and quality activities need to be embedded throughout the product
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January 6, 2026
EU Digital Omnibus Package: What’s Being Proposed
On 19 November 2025, the European Commission unveiled the Digital Omnibus package, a legislative proposal introducing targeted amendments to several
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December 17, 2025
Meet the Team: Maurice Veerkamp
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software
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December 17, 2025
EU Publishes Draft Rules for AI Regulatory Sandboxes
On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation
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November 18, 2025
Industry Calls for Digital Labels for Authorised Representatives and Importers
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the
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November 5, 2025
EU Commission Final Report on AI in Healthcare: Deployment, Barriers, and Regulatory Priorities
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the
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October 21, 2025
FDA’s New QMSR Rule: Aligning 21 CFR 820 with ISO 13485:2016
In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part
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September 26, 2025
Navigating UDI: GUDID vs EUDAMED, and How MDIS Helps You Comply
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems
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