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14:03
Case Study: When Underestimating Risk Leads to a Warning Letter
Lessons learned from a recent FDA warning letter highlighting systematic issues with risk analysis, CAPA and design controls.
 • 
Naveen Agarwal, Ph.D.
Medical Device Recalls - Part 1: High Level Overview
A high level overview of 283 Class I recalls of medical devices in the last 3 years.
 • 
Naveen Agarwal, Ph.D.
2
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.
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ISO 14971 Fundamentals: Characteristics related to safety
 • Naveen Agarwal, Ph.D.
5
Medical Device News Update - March 2025
 • Naveen Agarwal, Ph.D.
Webinar 10: Tips for medical device software risk analysis
 • Naveen Agarwal, Ph.D.
2
LTR 102: Collaboration that drives innovation, not delays
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
 • Naveen Agarwal, Ph.D.
Medical Device Recalls - Part 1: High Level Overview
 • Naveen Agarwal, Ph.D.
2

Case studies

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14:03
Case Study: When Underestimating Risk Leads to a Warning Letter
Lessons learned from a recent FDA warning letter highlighting systematic issues with risk analysis, CAPA and design controls.
 • 
Naveen Agarwal, Ph.D.
17:10
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.
11:22
Case Study: A Promising Device Fails in the Market Due to Usability Issues
5 years after acquiring a promising medical device, a major MedTech discontinued marketing following a Class I recall. Here are a few lessons learned…
 • 
Naveen Agarwal, Ph.D.
3

Webinars

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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.
2
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.

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AMA on Risk Management

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