Regulatory Strategy & Submissions
Is Regulatory and Medical Writing Really Something You Should Outsource?
In the fast-paced world of medical device and medical technology (MedTech), navigating regulatory pathways and ensuring compliance can be daunting...
Navigating the New Landscape — FDA’s Final Rule on Laboratory Developed Tests (LDTs)
On May 6, 2024, the FDA published its final rule on laboratory developed tests (LDTs) in the Federal Registrar, marking...
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...
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...