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
The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning
Health Canada has expanded the scope of its electronic Submission Template And Resource (eSTAR) pilot, giving medical device manufacturers a
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are
The new EU Artificial Intelligence Act (AI Act, 2024/1689) adds a layer of regulatory requirements for medical device firms already
On June 13, 2025, the U.S. Food and Drug Administration (FDA) issued a pivotal final rule reclassifying radiological computer-assisted detection
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