Subscribe
Sign in
Home
Podcast
Chat
Business Acumen
QMSR Compliance
Wall of Love
Archive
About
Medical Device Recalls Part 4: Focus on Ventricular Assist Devices
Part 4 of our deep dive series reveals why two rival heart pumps, built for the same intended use, ended up with such different safety records and…
Aug 13
2
1
15:57
Case Study: When Clues to a Future Recall Hide in Plain Sight
Lessons learned from a recent Class I recall highlight the importance of active signal monitoring, cross-referencing with other similar issues, and…
Aug 11
•
Naveen Agarwal, Ph.D.
1
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.
Most Popular
View all
ISO 14971 Fundamentals: Characteristics related to safety
Dec 20, 2023
•
Naveen Agarwal, Ph.D.
11
5
Medical Device News Update - May 2025
Jun 18
•
Naveen Agarwal, Ph.D.
1
Medical Device News Update - March 2025
May 7
•
Naveen Agarwal, Ph.D.
2
LTR 115: Startup Lessons from EU MedTech Shark Tank
Jul 18
6
LTR 102: Collaboration that drives innovation, not delays
Apr 18
5
Webinar 10: Tips for medical device software risk analysis
Jul 3, 2024
•
Naveen Agarwal, Ph.D.
6
2
Case studies
See all
Medical Device Recalls Part 5: Understanding Broader Context
One recall can change the entire perception of safety. Part 5 of our deep dive series looks beyond raw counts to show how impact-based metrics uncover…
Aug 27
•
Naveen Agarwal, Ph.D.
1
12:57
Case Study: Contrasting U.S. and EU Approaches to AI Regulation
What the U.S. vs EU AI regulatory divide means for MedTech quality, regulatory, and risk leaders navigating a rapidly changing landscape.
Aug 25
1
Medical Device Recalls Part 4: Focus on Ventricular Assist Devices
Part 4 of our deep dive series reveals why two rival heart pumps, built for the same intended use, ended up with such different safety records and…
Aug 13
2
1
Deep insights
See all
32:47
LTR 122: Tibor Zechmeister on PSUR Best Practices
Tibor Zechmeister talks about why PSUR should be a living snapshot of safety, and how best practices and AI can make compliance smarter, not harder.
Sep 5
2
31:58
LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Regulatory strategist Michelle Lott helps unpack how FDA’s shift to QMSR will reshape risk management, CAPA, and inspections, and what MedTech companies…
Aug 29
1
Medical Device Recalls Part 5: Understanding Broader Context
One recall can change the entire perception of safety. Part 5 of our deep dive series looks beyond raw counts to show how impact-based metrics uncover…
Aug 27
•
Naveen Agarwal, Ph.D.
1
Webinars
See all
Quick tips
See all
Risk management fundamentals
See all
Medtech news
See all
AMA on Risk Management
See all
Let's Talk Risk!
Building competence through content, community and conversations.
Subscribe
Recommendations
The FDA Group's Insider Newsletter
The FDA Group
What the FDA?
Steve Silverman
Clinical Evaluation Navigator
Hatem Rabeh
The Other Consultants: MedTech Quality & Regulatory Insights
Adam Isaacs Rae
Let's Talk Risk!
Subscribe
About
Archive
Recommendations
Sitemap
This site requires JavaScript to run correctly. Please
turn on JavaScript
or unblock scripts
