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Case study: A smart benefit-risk strategy for market entry via the De Novo pathway
Lessons learned from a smart strategy to demonstrate safety and effectiveness of a novel software device through evidence-based benefit-risk…
 • 
Ritam Priya
 and 
Naveen Agarwal, Ph.D.
Quick Tip: Software changes rapidly. Develop a framework for reassessing risks.
Many software changes are trivial and do not affect the user-interface. Consider developing a framework for re-assessing risks related to use-error…
LTR 74: AR/VR devices in MedTech
Insights from a Let's Talk Risk! conversation with Ritam Priya.
33:10
Overview of risk analysis techniques for system safety
FMEA continues to be the dominant risk analysis technique used in the medical device industry. It is time to expand our toolkit.
 • 
Naveen Agarwal, Ph.D.
1
Quick Tip: Use consensus standards database to identify state of the art
Identifying relevant state of the art for your medical device can be tricky. A good source is FDA's consensus standards database.
LTR 73: It's time to up our game on medical device cybersecurity
Deep insights from a conversation with Eric Henry.
 • 
Naveen Agarwal, Ph.D.
33:22
Mastering risk analysis for excellence in system safety
Introducing a new series on Let's Talk Risk! to help you build a solid knowledge of medical device system safety and commonly used risk analysis…
 • 
Naveen Agarwal, Ph.D.
Quick Tip: Design your medical device to be robust to use conditions
Designing a medical device just for the "happy case" is not sufficient. Consider using the principles of robust design to for safe and effective…
LTR 72: A clinician's insights on risk and collaboration in MedTech
Insights from a Let's Talk Risk! conversation with Dr. Olaf Hedrich
33:36

October 2024

Quick Tip: How MDs can collaborate to enhance medical device risk management
Clinicians with medical experience bring a unique perspective to safety risk management of medical devices that engineers lack. But clinicians also need…
Bonus feature: Free video lesson on the risk management process for medical devices
A special bonus feature for subscribers of Let's Talk Risk! newsletter. This is a video lesson from the on-demand ISO 14971 certification training…
 • 
Naveen Agarwal, Ph.D.
12:39
Quick Tip: Watch out for misaligned incentives that compromise resilience
In today's ever changing world, risk management alone is not sufficient. We need to build resilient systems and products. Misaligned incentives at…
© 2024 Naveen Agarwal, Ph.D.
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