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Risk Management
Medical Devices
FDA
Cybersecurity
In Vitro Diagnostics
Medical Device Industry
Quality Management
Artificial Intelligence
Product Change Control Processes
Machine Learning
Usability Engineering
IEC 62366-2
Healthcare Delivery
Ecosystem
ISO 13485
Regulatory Compliance
Augmented Reality
Patient Safety
Data Diversity
Quality Assurance

Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management proces... more

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Latest Episodes

Summary

“A company can become world class the day the quality team decides.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Ganesh Sabat, former former CEO of Sahajanand Medical Technologies (SMT) and now Founder & Managing... more

Summary

“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”

As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion persists across the MedTech in... more

YouTube

Summary

“Risks occur. They happen but they don’t exist… hazards do.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits with Jean Blom, a QMS & Audit Specialist and risk management trainer with deep experience across ISO 13485 auditing... more

YouTube

Summary

“Management review is no longer a check-the-box exercise. It’s the most powerful lever leaders have to drive proactive quality.”

In this episode of the Let’s Talk Risk Podcast, Naveen Agarwal sits down with Jennifer Mascioli-Tudor, an exper... more

YouTube

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Recent Guests

Holly Cotter
Co-founder of IndyMedTech and certified regulatory affairs professional with a biomedical engineering background.
IndyMedTech
Episode: LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Jean Blom
Risk management expert with significant experience in MedTech
Episode: LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management
Jennifer Mascioli-Tudor
A highly accomplished professional in the industry with expertise in quality management systems and regulatory compliance.
JMT Consulting, Career Catalyst Circle
Episode: LTR 143: Jennifer Mascioli-Tudor on Leading Proactive Quality in the QMSR Era
Florian Tolkmitt
Managing director of PRO-LIANCE GLOBAL SOLUTIONS, specializing in clinical evaluation and risk management for medical devices.
PRO-LIANCE GLOBAL SOLUTIONS
Episode: LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Ashkon Rasooli
Expert in software as a medical device and quality management systems
EnGenius Solutions
Episode: LTR 141: Ashkon Rasooli on Applying an Agile Mindset to Risk-Based Quality Systems Under QMSR
Pujitha Gourabathini
Manager of quality assurance and risk management at Becton Dickinson.
Becton Dickinson
Episode: LTR 140: Pujitha Gourabathini on Connecting Risk Management and Design Controls
Priya Setty
Regulatory affairs manager at Ologic with a background in occupational therapy and hospital administration.
Ologic
Episode: LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Adam Isaacs Rae
Managing Director of Quality and Regulatory at The Other Consultants
The Other Consultants
Episode: LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Allison Komiyama
Regulatory affairs professional with a PhD in neuroscience from Stanford.
Episode: LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech

Host

Dr. Naveen Agarwal
Host and expert in risk management within the medical device industry, leading discussions with various industry professionals.

Chart Rankings

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Apple Podcasts
#157
South Korea/Technology

Talking Points

Recent interactions between the hosts and their guests.

LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Q: Can you briefly describe what a quality plan is and what are some essential elements?
A quality plan outlines quality issues and identifies necessary actions to address gaps, focusing on a holistic approach rather than specific products.
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Q: What is your view on the alignment between MDSAP model and QMSR compliance?
MDSAP won't cover everything required for QMSR compliance, so manufacturers need to be cautious and prepare accordingly.
LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Q: What are you hearing about QMSR transition in your circles?
There's not enough discussion about QMSR among startups and smaller companies, who are the most likely to be impacted.
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Q: Is there a mandatory requirement for clinical trials for every medical device?
No, there's no mandatory requirement for a clinical trial for every medical device, though clinicians should perform evaluations first to identify outcome measures.
LTR 142: Florian Tolkmitt on Clinical Evaluation, Risk, and the New ISO Draft Standard
Q: How frequently should available knowledge be tracked?
Available knowledge includes state-of-the-art but should not limit understanding to clinical practices; it should encompass all relevant information, potentially on a continuous basis.

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Frequently Asked Questions About Let's Talk Risk!

What is Let's Talk Risk! about and what kind of topics does it cover?

The content centers around risk management within the highly regulated medical device industry, where conversations frequently address the intricate balance between compliance, innovation, and practical application. Topics discussed encompass a range of challenges, from adapting to new regulatory frameworks like the Quality Management System Regulation (QMSR) to exploring the role of artificial intelligence in ensuring patient safety and enhancing medical device efficacy. The narrative emphasizes collaboration among industry professionals to share best practices and insights, covering themes such as benefit-risk evaluation, human factors in device design, and proactive compliance strategies as core areas of focus. A noteworthy aspect of thi... more

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Which podcasts are similar to Let's Talk Risk!?

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1. Medical Device made Easy Podcast
2. Global Medical Device Podcast powered by Greenlight Guru

How many episodes of Let's Talk Risk! are there?

Let's Talk Risk! launched 2 years ago and published 156 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on Let's Talk Risk!?

Recent guests on Let's Talk Risk! include:

1. Holly Cotter
2. Jean Blom
3. Jennifer Mascioli-Tudor
4. Florian Tolkmitt
5. Ashkon Rasooli
6. Pujitha Gourabathini
7. Priya Setty
8. Adam Isaacs Rae

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