The European Health Data Space (EHDS) Regulation was published in the Official Journal of the European Union on 5 March
MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A) Regulatory compliance in the medical device industry can feel
Navigating the e-QMS Landscape: Insights from the European SaMD Meetup Ivo Flipse from MedQAIR co-hosted the European SaMD Meetup alongside
South Korea’s Ministry of Food and Drug Safety (MFDS) announced on January 24th that it has released the first-ever guidelines
In a move that has taken many in the technology and legal sectors by surprise, the European Commission has withdrawn
On Wednesday, the International Medical Device Regulators Forum (IMDRF) finalized two highly anticipated technical documents outlining guiding principles for good
The U.S. FDA (Food and Drug Administration) recognized the Common Vulnerability Scoring System (CVSS) v4.0 on December 23, 2024, as
On January 7, 2025, the MDCG 2023-3, a guidance document from the Medical Device Coordination Group (MDCG) of the European
The United States Food and Drug Administration (FDA) released a draft guidance document on January 6, 2025, outlining its recommendations
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