Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for star...
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Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medica...
The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed th...
In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualificat...
In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have...