Global regulatory requirements for medical devices differ widely in scope and interpretation. These disparities can delay product launches, elevate compliance…
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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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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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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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On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
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Back in June, our Senior Operations Consultant and Biocompatibility Specialist Dr. Silvio Peng shared five important updates from the draft ISO…
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