Let's Talk Risk!

Home
Podcast
Business Acumen
QMSR Compliance
Wall of Love
Archive
About
Mastering risk analysis for excellence in system safety
Introducing a new series on Let's Talk Risk! to help you build a solid knowledge of medical device system safety and commonly used risk analysis…
 • 
Naveen Agarwal, Ph.D.
33:36
LTR 72: A clinician's insights on risk and collaboration in MedTech
Insights from a Let's Talk Risk! conversation with Dr. Olaf Hedrich
Tuning into the Bottom Line: Why QA/RA Professionals Should Listen to Earnings Calls
Learn to speak the language of business by listening to how senior executives speak.
 • 
Naveen Agarwal, Ph.D.
2
Most Popular
View all
ISO 14971 Fundamentals: Characteristics related to safety
 • Naveen Agarwal, Ph.D.
5
Webinar 7: How to create a master harms list using standard codes
 • Naveen Agarwal, Ph.D.
1
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
 • Naveen Agarwal, Ph.D.
1
Medical Device News Update - July 2024
 • Naveen Agarwal, Ph.D.
Tuning into the Bottom Line: Why QA/RA Professionals Should Listen to Earnings Calls
 • Naveen Agarwal, Ph.D.
2
Webinar 10: Tips for medical device software risk analysis
 • Naveen Agarwal, Ph.D.
1

Case studies

See all
Case study: A smart benefit-risk strategy for market entry via the De Novo pathway
Lessons learned from a smart strategy to demonstrate safety and effectiveness of a novel software device through evidence-based benefit-risk…
 • 
Ritam Priya
 and 
Naveen Agarwal, Ph.D.
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
A mobile medical app crashing can cause a life-threatening emergency and send you to the hospital. It seems to have fallen through a crack in the…
 • 
Naveen Agarwal, Ph.D.
1
AI in MedTech #1: IDx-DR retinal software for early screening of diabetic retinopathy
A case study to illustrate benefit-risk assessment for an innovative AI-based screening device for early detection of diabetic retinopathy.
 • 
Naveen Agarwal, Ph.D.
2

Webinars

See all
48:31
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.
 • 
Naveen Agarwal, Ph.D.
1
54:26
Webinar 9: How to set up post-market surveillance
A review of ISO 14971 requirements and practical tips to set up an efficient and effective post-market safety surveillance process for your medical…
 • 
Naveen Agarwal, Ph.D.
56:41
Webinar 8: Case study discussion and Q&A
Watch now | A case study about a warning letter for miscalculating risk and a general Q&A session about risk management.
 • 
Naveen Agarwal, Ph.D.

Quick tips

See all

Risk management fundamentals

See all

Medtech news

See all

AMA on Risk Management

See all

LTR weekly digests

See all
Let's Talk Risk!
Let's Talk Risk!
Building competence through courses, case studies and community.
Recommendations
View all 6
On the Edge of Resilience
On the Edge of Resilience
Marco
The Quality Network
The Quality Network
Lesley Worthington
IronLine’s Substack
IronLine’s Substack
IronLine Consulting LLC
The FDA Group's Insider Newsletter
The FDA Group's Insider Newsletter
The FDA Group
Clinical Evaluation Navigator
Clinical Evaluation Navigator
Hatem Rabeh

Let's Talk Risk!

AboutArchiveRecommendationsSitemap
© 2024 Naveen Agarwal, Ph.D.
Privacy ∙ Terms ∙ Collection notice
Start WritingGet the app
Substack is the home for great culture