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Despite advances in trial design, digital health and patient engagement, recruitment remains one of the most critical bottlenecks in cardiovascular clinical trials, and many studies ...

Entering the European market has become significantly more complex under the Medical Device Regulation (EU) 2017/745 (MDR), making structured compliance a critical success factor for ...

Artificial-intelligence (AI)-driven medical software is increasingly being adopted in healthcare across Europe. Often referred to as AI-based software as a medical device (AI-SaMD) these systems ...

Cardiovascular diseases (CVDs) are the leading cause of mortality globally, accounting for approximately 17.9 million deaths annually, as reported by the World Health Organization (WHO). ...

A growing body of research highlights that nutrition is more than just basic nourishment — it plays a crucial role in shaping the long-term vitality ...

Navigating the complex landscape, often experienced as jungle, of regulatory requirements for clinical investigations with medical devices can feel like venturing into a dense jungle. ...