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Medical Device News Update - December 2024
FDA approvals, warning letters and Class I recalls issued during December 2024
Jan 29
•
Naveen Agarwal, Ph.D.
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Medical Device News Update - December 2024
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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…
Jan 27
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Quick Tip: Carefully consider human factors for AR/VR devices
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LTR 85: The problem with CAPA problem statements
Insights from a Let's Talk Risk! conversation with Jack Garvey.
Jan 24
1
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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…
Jan 20
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Quick Tip: Define the indications for use carefully for regulatory success
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LTR 84: Think of human factors for AI as levels of automation
Insights from a Let's Talk Risk! conversation with Shannon Hoste.
Jan 17
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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.
Jan 15
1
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LTR 83: Road to market for AI devices in the EU just got more complex
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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…
Jan 13
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Quick Tip: Risk-based approach is an operating philosophy, not a specific tool
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LTR 82: Tips for Regulatory Success with AI Devices in Radiology
Deep insights from a conversation with Dr. Jay Vaishnav.
Jan 10
•
Naveen Agarwal, Ph.D.
2
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LTR 82: Tips for Regulatory Success with AI Devices in Radiology
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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…
Jan 6
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Quick Tip: Medical device cybersecurity requires a new mindset
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LTR 81: 4 key themes in risk management and an upcoming conference
Deep insights from a conversation with Bijan Elahi.
Jan 3
•
Naveen Agarwal, Ph.D.
1
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LTR 81: 4 key themes in risk management and an upcoming conference
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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…
Jan 1
•
Naveen Agarwal, Ph.D.
1
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A free lesson and a special offer
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23:43
December 2024
Quick Tip: Promote a culture of collaboration with these tips
Risk management is a team sport. No one person has all the answers. Here are a few tips to help nurture a culture of collaboration for success in risk…
Dec 30, 2024
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Quick Tip: Promote a culture of collaboration with these tips
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