Summary FDA submissions for AI/ML-enabled medical devices rarely fail because of a single mistake – they unravel due to a
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers
Co-authored with Preethi Philip Under the MDD 93/42/EEC, the medical device industry lacked a serious level of transparency in the
The latest MHRA update outlines significant regulatory reforms in the medical device industry, with the goal of enhancing patient safety
Update, October 2026: Device registration in swissdamed has been mandatory since 1 July 2026, with a transitional period until 31
Under the MDD 93/42/EEC, the role of the medical device Distributor was largely unaddressed in the Medical Device legislation within
Today marks an important milestone for the European Union (EU). After a three year development period, the EU AI Act
As we prepare for the AI Act to take effect on August 1, 2024—20 days after its publication in the
Regulations are becoming more stringent by the day, with increased safety requirements for medical device manufacturers under the Medical Device
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