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The Software, AI and Digital Health Regulatory Knowledge Hub provides expert analysis and practical guidance on the evolving regulation of software-based medical technologies worldwide. Explore publications covering Software as a Medical Device (SaMD), artificial intelligence and machine learning, cybersecurity, digital health frameworks, clinical data considerations, and global regulatory requirements affecting the development, approval, and lifecycle management of digital medical technologies.
Regulatory Intelligence Pack: AI in MedTech
AI-enabled medical devices are now firmly in scope of multiple regulatory frameworks. This Regulatory Intelligence Pack provides a curated set of high-impact AI insights, designed to offer you clarity and practical considerations. Read More...
£149.00
Use of artificial intelligence in literature screening for regulatory compliance
Discover how AI tools can streamline literature reviews for clinical evaluation Read More...
£50.00
Levels of autonomy in medical AI: implications for risk, regulation, and clinical practice
An insightful analysis of autonomous medical AI, exploring regulatory challenges, risk management, and how emerging AI technologies may reshape clinical practice and healthcare delivery Read More...
£35.00
Cybersecurity in the USA – developing a NIST SSDF-based Profile for low and moderate risk medical device applications
Strengthen cybersecurity compliance and apply the NIST SSDF framework to build secure, risk-appropriate development processes for medical device software Read More...
£50.00
India’s regulatory framework for software as a medical device (SaMD)
Enter India’s SaMD market: understand the regulatory framework, approval process, and compliance essentials for software as a medical device Read More...
£45.00
The many ambiguities of the European Union’s Artificial Intelligence Act
Navigate the regulatory complexities of AI-powered medical devices with insights on the EU Artificial Intelligence Act: understand its horizontal scope and the implications for high-risk systems Read More...
£45.00
Clinical data and the federated learning concept for an AI/ML device
Understand how federated learning could be used to train AI/ML medical devices while protecting patients' health data Read More...
£40.00
Canadian regulatory framework for software-based medical devices and emerging technologies
From SaMD to AI, Canada’s regulatory approach is evolving - understand what it means for your software-driven medical technologies Read More...
£40.00
Best practices for medical device cybersecurity planning from a US perspective
Ensure robust cybersecurity measures for your devices by following proven best practices from a US perspective, safeguarding both data and patient safety Read More...
£35.00
Japan’s regulatory requirements for Software as a Medical Device (SaMD)
Navigate Japan's complex SaMD regulations with this comprehensive guide, ensuring compliance and smooth market entry for your software-based medical products Read More...
£35.00
Registration checklist for Software as a Medical Device in Mexico according to Article 83 of the ‘Health Supplies Regulation’
Simplify the registration process for your Software as a Medical Device in Mexico with this detailed, regulation-compliant tabulated checklist Read More...
£35.00
