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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
21 hours ago56 min read


AI in Pharma 2025: Who’s Leading the Charge and Why It Matters
The convergence of artificial intelligence and pharmaceutical innovation is no longer a distant vision; it’s today’s reality. With a projected market size of $116.49 billion by the end of 2025 and a 27% compound annual growth rate (CAGR), AI in pharma is reshaping everything from drug discovery to diagnostics.

Camilla Costa
Jul 43 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


Unlocking the Potential of Machine Learning Frameworks in Medical Device Innovation and Expertise
In today's fast-paced world, technology is making remarkable changes across many sectors. Machine learning (ML) frameworks stand out as a...

Camilla Costa
May 204 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


Navigating the Unknown: Key Principles of Good Machine Learning Practices in Medical Device Development
The rapid growth of machine learning (ML) in recent years has introduced new possibilities in healthcare. These advancements offer the...

Camilla Costa
Mar 54 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


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


AI in Pharma: almost half a century old, news.
AI in Pharma: almost half a century old, news. AI didn’t crash into pharma. It drifted in, slowly, quietly, and no one looked twice. It’s been part of the story for nearly 50 years.

BC Regulatory Blog
Nov 1, 20242 min read
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