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EU AI Act and Its Application in Developing Rare Disease Therapies for Neurological Disorders
The EU AI Act (Artificial Intelligence Act Regulation EU 2024/1689), which came into force on 1 August 2024, establishes a harmonised framework for regulating AI systems. It impacts the use of AI in medical settings, particularly when integrated with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Camilla Costa
Jul 275 min read


AI in Pharma: Job Killer or Opportunity for Innovation and Growth?
In this article, we will explore how AI is reshaping the pharmaceutical landscape and examine its implications for the workforce, presenting a balanced view on the potential benefits and challenges ahead.

Camilla Costa
Jul 214 min read


June 2025 Regulatory Update: What MDR, IVDR & the AIA Mean for MedTech
In 2025, manufacturers of AI-powered medical devices face a new regulatory reality. The European Union has introduced the Artificial Intelligence Act (AIA). If your device falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR), the AIA is mandatory. It’s now a core part of your compliance strategy.

Camilla Costa
Jun 118 min read


Structuring Clinical Trials for AI-Enabled Drug Discovery Platforms: A Comprehensive Guide
In the fast-paced world of drug discovery, artificial intelligence (AI) has become essential, transforming the way researchers identify...

Camilla Costa
May 124 min read


Unlocking Key Resources for Navigating FDA and EU Regulations in Digital Health
The digital health landscape is evolving quickly, thanks to advances in technology like artificial intelligence (AI) and machine learning...

Camilla Costa
Nov 6, 20245 min read
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