Stay informed on the latest updates in medical device regulatory affairs to enter regulated markets fully prepared.
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The United States Food and Drug Administration (FDA) released a draft guidance document on January 6, 2025, outlining its recommendations
The latest MHRA update outlines significant regulatory reforms in the medical device industry, with the goal of enhancing patient safety
The Actors module of the Swissdamed medical devices database is currently operational as of August 6, 2024. This module facilitates
Today marks an important milestone for the European Union (EU). After a three year development period, the EU AI Act
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