FDA considerations for GenAI-enabled medical devices
On 18 August 2026, the FDA’s CDRH published “Considerations for the Regulation of Generative AI-Enabled Medical Devices”, a discussion paper…
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EN 18286 | What’s new & what’s the impact?
Last month (July 2026), CEN & CENELEC published the European Standard EN 18286, which defines a QMS specifically to meet…
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MDR 2.0 & EU AI Act | Implications for AI in MedTech
The Commission’s proposal COM (2025) 1023 final (widely known as MDR 2.0) aims to simplify and streamline the MDR by…
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How to overcome the CAPA flood
The goal of a CAPA (Corrective and Preventive Action) is to solve a problem or issue. When this goal is…
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MDR 2.0 proposal | Key implications for Clinical Affairs
The EU Commission’s proposal COM (2025) 1023 final – widely referred to within the medical device industry as MDR 2.0,…
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Overcoming the regulatory challenges to achieve global market access
Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
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AI Index Report 2026 | Key takeaways
The ninth edition of the AI Index Report has been released – and for the first time, it features standalone…
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AI, ML, & Medical Devices | A comprehensive overview
Artificial Intelligence (AI) and Machine Learning (ML) in medical devices are reshaping disease prevention, diagnosis, and management. The technologies enable…
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