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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…
Congenius
MedTech news roundup February 2026
Our MedTech news for February 2026 covers further evolution for global device regulation – with new EU harmonised standards, a…
Congenius
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…
Congenius
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…
Congenius
MedTech news roundup January 2026
Welcome back – and Happy New Year from our Congenius Knowledge Team! Our MedTech roundup for January 2026 kicks off…
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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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2025 – that’s a wrap!
It’s been an exciting and rewarding year at Congenius. As we navigated 2025, our team achieved a number of meaningful…
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EU proposed MDR & IVDR update | What’s in the proposal?
On 16 December 2025, the European Commission published a proposal to amend the EU regulatory framework for medical devices and…
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