Archive - Let's Talk Risk!

LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation

Insights from a Let's Talk Risk! conversation with Amit Guruprasad

18 hrs ago

32:13

Quick Tip: Treat clinical evaluation as a process, not a report

Insights from a conversation with Florian Tolkmitt

Jul 22

LTR 59: Tips for clinicians transitioning into a medical safety role in MedTech

Insights from a Let's Talk Risk! conversation with Dr. Juan Daccach

Jul 19

41:22

Regulating generative AI needs a new approach. Here is one idea.

Human-like AI agents are coming soon to healthcare, but risks are not fully understood and the regulatory framework is lagging behind the technology…

Jul 17 •

Naveen Agarwal, Ph.D.

Quick Tip: Make sure everyone has the same understanding of risk terminology

Insights from a conversation with Hugo Felix

Jul 15

LTR 57: It's time to focus on supply chain resiliency not just supplier management

Insights from a Let's Talk Risk! conversation with Marco Felsberger

Jul 12

34:08

Business acumen - new LTR feature to help you achieve the success you deserve

Because technical knowhow alone is not sufficient to grow your QA/RA career in MedTech, we are launching a new section to help you build business…

Jul 10 •

Naveen Agarwal, Ph.D.

Quick Tip: A simple trick to establish a risk policy

There is no requirement to have a standalone policy for risk acceptability. There is a simple way to be both compliant and effective.

Jul 8

LTR 56: How to communicate effectively with senior management

Insights from a Let's Talk Risk! conversation with Victor Mencarelli

Jul 5

31:27

Webinar 10: Tips for medical device software risk analysis

An overview of key challenges and tips for analyzing the risks of medical device software failures.

Jul 3 •

Naveen Agarwal, Ph.D.

48:31

Quick Tip: Integrate supplier risk with product risk in your FMEAs

Insight from a conversation with Kevin Posey

Jul 1

June 2024

LTR 55: FDA warning letter analysis, IVD risk management and career tips with Dr. Emanuel Tkach

Deep insights from a conversation with Dr. Emanuel Tkach.

Jun 28 •

Naveen Agarwal, Ph.D.

56:20

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