Medical Devices
Medical Device Regulation in the UK
Overview of Changes to UK Medical Device Markets Since the United Kingdom (U.K.) left the European Union (EU) at the...
Navigating Notified Body Feedback for Clinical Evaluations: The 5 Most Common CER Flaws & How to Avoid Them
In the field of medical devices, ensuring compliance with regulatory standards is preeminent. Notified bodies play a crucial role in...
Navigating FDA Proposed Changes to the Regulation of Laboratory Developed Tests and In Vitro Diagnostic Products
On September 29, 2023, FDA proposed to extend the definition of an in vitro diagnostic (IVD) to include laboratory developed...
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....
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...
Post-Market Clinical Follow-Up (PMCF): Best Practices for Success
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Avania Market Access: Comprehensive Strategy for Diagnostics Coverage, Coding, and Payment
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