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Life Sciences Blog

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https://7030766.fs1.hubspotusercontent-na1.net/hubfs/7030766/MDSW%20for%20Start-ups%20A%20Practical%20Guide%20to%20Compliant%20Medical%20Software%20Development.jpg

MDSW for Startups: A Practical Guide to Compliant Medical Software Development

Medical Device Software (MDSW) development can feel like a regulatory labyrinth, especially for start-ups with limited resources. But here’s the good news:...
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MDR & Cybersecurity: What Your Technical File Needs to Prove

Cybersecurity has become a fundamental requirement under the Medical Device Regulation (MDR). Medical device manufacturers must now actively demonstrate...
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Impact of the AI Act on the MedTech and Life Sciences Industry

The AI Act was formally adopted by the full European Parliament on 13 March, and we have reviewed the current text to form our initial impressions of the...
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Navigating Project Complexities: QbD’s Project Management Process for Qualification and Validation Projects

In the world of life sciences, ensuring the safety and efficacy of products is paramount. Qualification and validation projects play a pivotal role...
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AI and machine learning validation: strategies and examples

In the life science industry, Artificial Intelligence (AI) and Machine Learning (ML) validation have been the buzzwords of the past year. Every...
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