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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
Navigating the Future: A Strategic Roadmap for AI-Enabled Neurotech/MedTech Device Registration and Market Access in the EU, US, and UK
Navigating the Future of Artificial Intelligence (AI) into Neurotechnology and medical technology (MedTech) is poised to revolutionise healthcare, offering unprecedented diagnostic and therapeutic capabilities.
Camilla Costa
Jul 1456 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
Understanding the FDA Digital Health Software Precertification Program and Its Impact on Your Innovations
The rapid growth of technology in healthcare has opened new doors for innovation, especially in digital health software. Developers are...
Camilla Costa
Jan 93 min read
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