In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part 820 to incorporate ISO 13485:2016
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems have been adopted worldwide to
At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of experience, perspective, and commitment to
At MedQAIR, we combine regulatory expertise with a passion for building bridges, connecting continents, linking innovators with compliance, and uniting people who share deep industry
Navigating post-market compliance under MDR/IVDR has never been more complex. As regulatory demands rise, responsibility no longer rests solely with the manufacturer, it extends across
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers and Authorised Representatives of medical
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 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the rules for in vitro diagnostic
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
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