A medical device quality system has to do more than document procedures. It needs to give an organisation a controlled
An overview of the first episode of NEN’s podcast on AI in healthcare AI keeps turning up across everyday care,
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
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