On 19 November 2025, the European Commission unveiled the Digital Omnibus package, a legislative proposal introducing targeted amendments to several EU digital regulations. This package
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software as a Medical Device (SaMD),
On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation of AI regulatory sandboxes under
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the European Commission to allow Authorised
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the deployment of AI in healthcare.
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
The South African Health Products Regulatory Authority (SAHPRA) has published its first consolidated requirements for Artificial Intelligence and Machine Learning (AI/ML)-enabled medical devices and IVDs,
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