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Medical Device News Update - August 2024
FDA approvals, warning letters and Class I recalls issued during August 2024
 • 
Naveen Agarwal, Ph.D.
Quick Tip: PCCP is a great tool, use it with care
Predetermined Change Control Plan (PCCP) is a new regulatory scheme that can help you get to market faster. But it is not for every company or every…
LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
Insights from a Let's Talk Risk! conversation with Phil Deming.
33:59
Quick Tip: To be successful in a startup, don't try to do it all alone
Startups have a ton of energy and excitement, but not a whole lot of resources. Know the gaps for commercial success and don't try to do it all alone.
LTR 65: Demystifying risk-based approach vs. risk management
Insights from a Let's Talk Risk! conversation with Steve Gompertz.
35:14
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
A mobile medical app crashing can cause a life-threatening emergency and send you to the hospital. It seems to have fallen through a crack in the…
 • 
Naveen Agarwal, Ph.D.
1
Quick Tip: Understand terminology first before going deep into regulations
Medical device regulations are complex and continuously evolving. Focus first on understanding key terminology and the big picture before going into…

August 2024

LTR 64: Opportunities and challenges to leverage PCCP for speed to market
Deep insights from a conversation with Yu Zhao.
 • 
Naveen Agarwal, Ph.D.
29:30
Medical Device News Update - July 2024
FDA approvals, warning letters and Class I recalls issued during July 2024
 • 
Naveen Agarwal, Ph.D.
Quick Tip: Build credibility through honest communication
What you say, and how you say it affects your credibility. Match your communication with the level of confidence you have in the information.
LTR 63: A lawyer's perspective on the QMSR transition
Insights from a Let's Talk Risk! conversation with Neil Di Spirito.
35:50
Tuning into the Bottom Line: Why QA/RA Professionals Should Listen to Earnings Calls
Learn to speak the language of business by listening to how senior executives speak.
 • 
Naveen Agarwal, Ph.D.
2
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