Regulatory Strategy & Submissions
Guidance on Exemptions From The Requirement to Perform Clinical Investigations Pursuant to Article 61(4)-(6) MDR
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A Brief Guide: How the MHRA Regulates Healthcare Software and AI in the UK
In the rapidly evolving field of healthcare, software has become an integral component. Recently, an update on the “Software and...
Navigating the Regulatory Maze of the FDA: A Report of the Top 10 Markets for AI/ML-Enabled Medical Devices
Introduction The intersection of artificial intelligence and machine learning (AI/ML) with healthcare is nothing short of revolutionary. Yet, this fusion...
The FDA’s Approach to AI/ML in Medical Devices
The integration of artificial intelligence (AI) and machine learning (ML) in medical devices represents a turning point in healthcare innovation....
Racial and Ethnic Diversity in FDA Regulated Clinical Trials
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Europe’s Strategy on Artificial Intelligence
In our previous blog post “The EU’s AI Act and Medical Device Research,” we outlined the proposed Artificial Intelligence Act...
Avania IVD Solutions: A Fully Integrated Approach to Diagnostics Product Strategy
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The EU’S AI Act: Navigating the New Landscape of Artificial Intelligence Regulation in Medical Device Research
Artificial intelligence (AI) has become an integral part of our daily lives, influencing everything from personal devices to large-scale industrial...
The Era of MDR & IVDR Evaluation: How Our CER Framework Accelerates Medical Writing
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5 Ways to Find MedTech Global Market Efficiencies Now
Pursuing market approval for medical devices that will be used in both the EU and the U.S. is more complex...