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Medical Device News Update - December 2024
FDA approvals, warning letters and Class I recalls issued during December 2024
 • 
Naveen Agarwal, Ph.D.
Quick Tip: Carefully consider human factors for AR/VR devices
Applications of augmented and virtual reality are growing fast in medical devices. They also present unique challenges for human factors engineering as…
LTR 85: The problem with CAPA problem statements
Insights from a Let's Talk Risk! conversation with Jack Garvey.
31:30
Quick Tip: Define the indications for use carefully for regulatory success
Looking to get FDA approval for your AI/ML based medical device? Define the indications for use carefully because that will affect how FDA will judge…
LTR 84: Think of human factors for AI as levels of automation
Insights from a Let's Talk Risk! conversation with Shannon Hoste.
34:29
LTR 83: Road to market for AI devices in the EU just got more complex
Deep insights from a conversation with Florian Tolkmitt.
27:30
Quick Tip: Risk-based approach is an operating philosophy, not a specific tool
It is a mindset, the thinking about risk and then deciding an appropriate course of action. The answer might be applying the tools and principles of…
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
Deep insights from a conversation with Dr. Jay Vaishnav.
 • 
Naveen Agarwal, Ph.D.
28:54
Quick Tip: Medical device cybersecurity requires a new mindset
Medical devices no longer operation in isolation, but as a part of the broader ecosystem of healthcare delivery. Identifying and managing cybersecurity…
LTR 81: 4 key themes in risk management and an upcoming conference
Deep insights from a conversation with Bijan Elahi.
 • 
Naveen Agarwal, Ph.D.
29:49
A free lesson and a special offer
Start the new year strong by boosting your expertise in medical device risk management. Here is a video lesson on post-market surveillance and a special…
 • 
Naveen Agarwal, Ph.D.
23:43

December 2024

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