Navigating MDR: Fresh Insights and Updates
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software
In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems
At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of
At MedQAIR, we combine regulatory expertise with a passion for building bridges, connecting continents, linking innovators with compliance, and uniting
Navigating post-market compliance under MDR/IVDR has never been more complex. As regulatory demands rise, responsibility no longer rests solely with
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
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