Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
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Our MedTech news for April 2026 covers updates on device classification and the expansion of WET devices under the EU…
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The ninth edition of the AI Index Report has been released – and for the first time, it features standalone…
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This year marks a special milestone for Congenius, as we celebrate our 10-year anniversary. Reflecting on the journey taken this…
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Artificial Intelligence (AI) and Machine Learning (ML) in medical devices are reshaping disease prevention, diagnosis, and management. The technologies enable…
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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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In 2024, the regulatory environment in the EU regarding data became more complex, as three horizontal digital EU Regulations and…
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