Archive - Let's Talk Risk!

Quick Tip: A Great Product is Not Enough. You Also Need a Good Story.

The case of a promising medical device that solved a tough clinical problem offers a valuable lesson. You need to tell a good story to your users to…

16 hrs ago

LTR 117: Queenita Fernandes on Smart Use of AI for Clinical Evaluation

We now have several AI-driven tools that can be used to review clinical literature. Use them in a smart, collaborative manner to achieve the desired…

Aug 1

29:52

July 2025

Medical Device Recalls Part 3: Focus on Electrosurgical Cutting & Coagulation Devices

Part 3 of our deep dive series on medical device recalls spotlights what thousands of adverse event reports reveal about hidden design vulnerabilities…

Jul 30 •

Naveen Agarwal, Ph.D.

A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices

Key highlights, challenges and recommendations for Quality, Regulatory and Risk professionals to comply with FDA's expectations for Cybersecurity in…

Jul 28

16:31

LTR 116: Priyanka Murawala on ISO 10993 Update, Biocompatibility, Learning from Recalls

Insights from a Let's Talk Risk! conversation with Priyanka Murawala.

Jul 25

26:37

Medical Device News Update - June 2025

FDA device approvals, warning letters, adverse events and recalls issued during June 2025

Jul 23 •

Naveen Agarwal, Ph.D.

Quick Tip - Consider Lifecycle Management of Your Risk Management Plan

ISO 14971 requires a documented risk management plan in the risk management file. Consider adding requirements for lifecycle management of your plan as…

Jul 21

LTR 115: Startup Lessons from EU MedTech Shark Tank

Watch now | Insights and strategies from Dr. Michael Lichtenberg on what it takes for MedTech startups to succeed in Europe's complex regulatory and…

Jul 18

32:18

Medical Device Recalls - Part 2: Focus on Ventilator Design Issues

Ventilator recalls accounted for 10% of the 57 Class I recalls related to Device Design issues during July 2022-May 2025 timeframe. Here is a closer…

Jul 16 •

Naveen Agarwal, Ph.D.

Quick Tip - Tune Into FDA Direct Podcast with Commissioner Makary

If you want to stay updated with latest FDA news and priorities, tune into the FDA Direct podcast with Commissioner Marty Makary.

Jul 14 •

Naveen Agarwal, Ph.D.

LTR 114: What QA/RA Professionals Need to Know About Rapidly Growing MedTech in India

Insights from a Let's Talk Risk! conversation with Sanjay Arudi.

Jul 11

31:11

How Quality Can Help Overcome MedTech R&D Challenges

MedTech innovation is essential to drive growth, but R&D productivity is slowing down. Quality has an opportunity to lead compliant innovation in a…

Jul 9 •

Naveen Agarwal, Ph.D.

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