On 17 June 2026, the European Commission published the reference of EN ISO 15223-1:2021/A1:2025 in the Official Journal of the
At MedQAIR, we know that strong regulatory and quality systems are built on both experience and continuous learning. As medical
At MedQAIR, we work with professionals who understand that regulatory and quality activities need to be embedded throughout the product
On 19 November 2025, the European Commission unveiled the Digital Omnibus package, a legislative proposal introducing targeted amendments to several
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software
On 3 December 2025, the European Commission released a 12-page draft Implementing Regulation (Ares(2025)10569703) establishing detailed rules for the operation
A coalition of leading European associations: MedTech Europe, AESGP, COCIR, and Euromcontact, has published a joint position paper urging the
Overview of the EU AI in Healthcare Study In August 2025, the European Commission released a final report on the
In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part
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