Archive - Let's Talk Risk!

Quick Tip: Cybersecurity is more than data security for medical devices

Security of data is no longer the only concern for cyebersecurity. When it comes interconnected medical devices, ensuring patient safety is a bigger…

Mar 10

LTR 95: The case for software risk management in AI-driven home health devices

Insights from a Let's Talk Risk! conversation with Erhan Ilhan.

Mar 7

31:09

LTR 94: The road ahead for PCCPs and AI/ML amidst chaos at the FDA

Watch now | Deep insights from a conversation with Yu Zhao.

Mar 5

28:43

Quick Tip: Apply good usability practices for device safety and market success

If done right, usability engineering can help you identify problems early, implement innovative user-friendly solutions, and launch successful products.

Mar 3

February 2025

LTR 93: AI use cases in MedTech regulatory applications

Insights from a Let's Talk Risk! conversation with Michelle Wu.

Feb 28

32:56

LTR 92: Understanding the notified body perspective on clinical evaluation

Deep insights from a conversation with Amie Smirthwaite.

Feb 26

30:08

Quick Tip: IEC 60601 is more than just electrical safety

IEC 60601 is an important safety standard for medical devices. But it addresses more than just electrical safety. Here is the latest update on its…

Feb 24

LTR 91: International conference on medical device safety risk management

Bijan Elahi talks about the upcoming International Conference no Medical Device Safety Risk Management in Amsterdam, April 23-25, 2025.

Feb 21

30:49

Medical Device News Update - January 2025

FDA approvals, warning letters and Class I recalls issued during January 2025

Feb 19 •

Naveen Agarwal, Ph.D.

Quick Tip: Drive risk decisions using data, not emotions

Data should inform your decisions about risk, whether customer risk or producer risk, and not emotions. Gather as much information as possible before…

Feb 17

LTR 90: Lead with empathy to grow your Quality career

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

Feb 14

34:16

LTR 89: Navigating uncertain times at the FDA

Deep insights from a conversation with Steve Silverman.

Feb 12

30:01

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