Let's Talk Risk!

Home
Podcast
Business Acumen
QMSR Compliance
Wall of Love
Archive
About
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
Deep insights from a conversation with Dr. Jay Vaishnav.
 • 
Naveen Agarwal, Ph.D.
28:54
Quick Tip: Medical device cybersecurity requires a new mindset
Medical devices no longer operation in isolation, but as a part of the broader ecosystem of healthcare delivery. Identifying and managing cybersecurity…
LTR 81: 4 key themes in risk management and an upcoming conference
Deep insights from a conversation with Bijan Elahi.
 • 
Naveen Agarwal, Ph.D.
29:49
A free lesson and a special offer
Start the new year strong by boosting your expertise in medical device risk management. Here is a video lesson on post-market surveillance and a special…
 • 
Naveen Agarwal, Ph.D.
23:43

December 2024

Quick Tip: Promote a culture of collaboration with these tips
Risk management is a team sport. No one person has all the answers. Here are a few tips to help nurture a culture of collaboration for success in risk…
LTR 80: Building safety by design into medical devices
Insights from an open conversation with Alex Saegert.
34:01
Medical Device News Update - November 2024
FDA approvals, warning letters and Class I recalls issued during November 2024
 • 
Naveen Agarwal, Ph.D.
Quick Tip: PCCP is a great tool, but apply it strategically
Predetermined Change Control Plan (PCCP) is a great tool to accelerate innovation, but you need a strategy to apply it effectively in managing your…
LTR 79: Tips for SaMD development and success with FDA
Insights from an open conversation with J. David Giese.
31:31
Navigating Tricky Conversations with Senior Executives
In this guest post, Lesley Worthington offers 5 tips for getting your highly technical message across when communicating with senior executives.
 • 
Lesley Worthington
Quick Tip: Improve your CAPA problem statement with GenAI
GenAI offers a unique opportunity to upgrade your QMS processes, including CAPA, for consistency, compliance and effectiveness.
LTR 78: New challenges in managing risks of software in IVDs
Insights from an open conversation with Megan Kane.
30:38
© 2025 Naveen Agarwal, Ph.D.
Privacy ∙ Terms ∙ Collection notice
Start WritingGet the app
Substack is the home for great culture