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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The AI Act | An updated overview
As mentioned in last week’s article – The Data Act’s relevance in 2026, back in 2024, the EU regulatory environment…
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The Data Act’s relevance in 2026
In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and…
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Sustainability in plastics manufacturing for medical devices
Sustainability remains one of the most complex challenges facing the MedTech industry. It’s a broad, often polarising topic, and many…
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