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EU Notified Body Timelines: New MDR & IVDR Rules for Predictable CE Marking
The European Commission has adopted Implementing Regulation (EU) 2026/977, establishing harmonized and binding timelines for Notified Body conformity…
4 months, 1 week ago
UK MHRA Draft 2026 Medical Device Regulations: International Reliance and What's Next
The UK's MHRA has published draft medical device regulations set for 2026, introducing a new standalone framework for Great Britain. This episode bre…
4 months, 1 week ago
Mexico's New Medical Device Labeling Standard: COFEPRIS NOM-137-SSA1-2025 Compliance by 2027
In this episode, we break down Mexico's new comprehensive medical device labeling standard, NOM-137-SSA1-2025, published by the health regulator COFE…
4 months, 1 week ago
FDA's New Human Factors Guidance: Navigating Risk for 510(k) and PMA Submissions
In this episode, we explore the U.S. FDA's significant new guidance on Human Factors Engineering (HFE) for medical devices. The host breaks down the …
4 months, 1 week ago
The EUDAMED Countdown: Mandatory EU Device Registration Begins May 28, 2026
This episode details the critical EUDAMED deadline of May 28, 2026, when four key modules become mandatory for medical device and IVD manufacturers i…
4 months, 1 week ago
Winning the Heart: MedTech's Race for a Full Structural Heart Ecosystem by 2026
This episode explores the future of the structural heart market, a key growth area in MedTech. We discuss the technological advancements in imaging, …
6 months ago
The 2026 Neurotechnology Leap: Navigating BCI Commercialization, Reimbursement, and FDA Hurdles
This episode explores the imminent commercialization of Brain-Computer Interface (BCI) technology, moving it from a futuristic concept to a medical r…
6 months, 1 week ago
AI Scribes & Ambient Documentation: A 2026 Clinical Infrastructure Forecast
This episode explores the future of AI in healthcare, focusing on whether ambient documentation and AI-powered charting will become standard clinical…
6 months, 1 week ago
AI Chatbot Governance in MedTech: Balancing Safety and Speed in 2026
This episode explores the critical challenge MedTech leaders face in 2026 regarding the safe implementation of AI chatbots in healthcare. We discuss …
6 months, 1 week ago
The 2026 Diagnostics Revolution: Value Creation in Molecular Testing, Oncology, and Personalized Medicine
This episode explores the significant market shift toward molecular and genetic diagnostics projected for 2026. We analyze the key drivers behind thi…
6 months, 1 week ago