Let's Talk Risk!

Let's Talk Risk!

Home
Podcast
Chat
Business Acumen
QMSR Compliance
Wall of Love
Archive
About

June 2025

Quick Tip - Use FDA guidance and worksheet for benefit-risk evaluation
Benefit-risk evaluation of a medical device often proves to be challenging in practice. Here is a practical approach and a case study you can apply in…
 • 
Naveen Agarwal, Ph.D.
LTR 112: Overcoming organizational barriers to risk management through collaboration
Insights from a Let's Talk Risk! conversation with Brette Travaglio.
29:41
Best practices for success with PCCP
Predetermined Change Control Plan (PCCP) is an excellent tool for speed to market, but it requires strategic and disciplined approach. Consider these…
 • 
Naveen Agarwal, Ph.D.
2
Quick Tip: Beware of bias in your CAPA problem statement
Defining your CAPA problem statement prematurely without a good understanding of the event(s) introduces bias in your problem solving approach. This…
LTR 111: How to sustain and grow a community of practice in risk management
Insights from a Let's Talk Risk! conversation with Ronak Dunung.
29:04
Medical Device News Update - May 2025
FDA device approvals, warning letters, adverse events and recalls issued during May 2025
 • 
Naveen Agarwal, Ph.D.
Case Study: A Warning Letter Exposes Issues in Risk Analysis
Lessons learned from a recent FDA warning letter highlighting systemic issues in risk analysis, design verification and post-market vigilance for a…
 • 
Naveen Agarwal, Ph.D.
17:10
LTR 110: Focusing on reliability to build safe medical devices
Deep insights from a conversation with Mitra Soltani.
1
26:12
Industry snapshot: MedTech confronting tariff headwinds amidst tepid growth
Leading MedTech companies reported modest growth and more than $2 billion in cumulative anticipated tariff impact on earnings late 2025. Here is how…
 • 
Naveen Agarwal, Ph.D.
© 2025 Naveen Agarwal, Ph.D.
Privacy ∙ Terms ∙ Collection notice
Start writingGet the app
Substack is the home for great culture