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Let's Talk Risk! Podcast Let's Talk Risk! Podcast Where MedTech professionals gain clarity and confidence to navigate complex decisions. 慾望琦姬 慾望琦姬 琦琦艾姬 Diane's Tarot Diary: 我的塔羅日記 Diane's Tarot Diary: 我的塔羅日記 Diane Yang Gunfighter Life - Survival Guns Ammo Hunting Defense Tactics Gunfighter Life - Survival Guns Ammo Hunting Defense Tactics Michael Milito Osho Hindi Podcast Osho Hindi Podcast Govind Das Swami Blind Abilities Blind Abilities Blind Abilities Team Dojo Talks: A Chess Podcast Dojo Talks: A Chess Podcast IM Kostya Kavutskiy, IM David Pruess, GM Jesse Kraai BIG Life Devotional | Daily Devotional for Women BIG Life Devotional | Daily Devotional for Women Pamela Crim | Daily Devotional for Women Blind Abilities Blind Abilities BlindAbilities Team ZEIT WISSEN. Woher weißt Du das? ZEIT WISSEN. Woher weißt Du das? DIE ZEIT The Dentalpreneur Podcast w/ Dr. Mark Costes The Dentalpreneur Podcast w/ Dr. Mark Costes Dental Consulting The Birth Experience with Labor Nurse Mama The Birth Experience with Labor Nurse Mama Trish Ware, RN La palabra con nosotras con nosotros La palabra con nosotras con nosotros Alexander Zatyrka, SJ / ITESO / Radio Ibero León This One Time in Real Estate... This One Time in Real Estate... Mark Gellman Productive Therapist Podcast Productive Therapist Podcast Uriah Guilford, MFT Perfect Life Awakening Perfect Life Awakening iOM Radio Network - OMTimes Nincha - Podcast para aprender idiomas (pt - br) Nincha - Podcast para aprender idiomas (pt - br) Nincha English Vocabulary Help English Vocabulary Help English With Kayla TuttoLibri TuttoLibri Radio Number One EdTech Bites Podcast EdTech Bites Podcast Gabriel Carrillo Billianon Billianon Billianon Pivot: SHIFT Ahead Mastermind Pivot: SHIFT Ahead Mastermind James Shaw 鞠强教授:管理心理学 鞠强教授:管理心理学 管理心理学教授鞠强 楊照談書-臺北廣播電臺 楊照談書-臺北廣播電臺 楊照 The Happy Hustle Podcast The Happy Hustle Podcast Cary Jack NY Executive Podcast The Next Million Streams Could Be Yours NY Executive Podcast The Next Million Streams Could Be Yours NY Executive Podcast Network Sustainability Defined Sustainability Defined Nethra Rajendran and Cecilia Rios Cabalá Media | mp4 #kab_spa Cabalá Media | mp4 #kab_spa Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" Kabbalah Media | mp3 #kab_eng Kabbalah Media | mp3 #kab_eng Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" Kabbalah Media | mp4 #kab_eng Kabbalah Media | mp4 #kab_eng Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" Studying Kabbalah #kab_eng Studying Kabbalah #kab_eng Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" Каббала Медиа | mp3 #kab_rus Каббала Медиа | mp3 #kab_rus Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" Каббала Медиа | mp4 #kab_rus Каббала Медиа | mp4 #kab_rus Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" קבלה מדיה | mp4 #kab_heb קבלה מדיה | mp4 #kab_heb Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" קבלה מדיה | mp3 #kab_heb קבלה מדיה | mp3 #kab_heb Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" לומד קבלה #kab_heb לומד קבלה #kab_heb Bnei Baruch Kabbalah Education and Research Institute, Бней Барух – Ассоциация "Каббала Ла-Ам" 4biddenknowledge Podcast 4biddenknowledge Podcast Billy Carson 4biddenknowledge
Let's Talk Risk! Podcast

Educación

Let's Talk Risk! Podcast

Where MedTech professionals gain clarity and confidence to navigate complex decisions.

Case Study: Why FDA Cybersecurity Expectations Are Really QMS Expectations

July 10, 2026 7:00am 17 min

You cannot bolt cybersecurity onto a medical device at the end of development.FDA’s cybersecurity guidance makes a clear shift: cyber risk is now a quality system issue, a patient safety issue, and a lifecycle management...

LTR 160: IMSC26 Highlights - From Compliance to Proactive MedTech Safety

July 03, 2026 7:00am 47 min

Summary“The biggest takeaway was realizing that our perspectives on risk and safety are not isolated. They are shared, validated, and strengthened by others in the field.”In this special episode of the Let’s Talk Risk! c...

LTR 159: The Evolving Regulatory Landscape for AI in MedTech

June 26, 2026 7:00am 42 min

Summary“Stop thinking of AI as replacing humans. Think about humans staying in charge while AI is placed in the loop”Artificial intelligence is no longer a future concept in MedTech. It is already inside medical devices,...

Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions

June 19, 2026 7:00am 41 min

You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about u...

LTR 158: Three Questions To Keep Risk Connected to Decisions

June 12, 2026 7:00am 28 min

Summary“Tools do not remove uncertainty”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Vilma Nasteckiene, PhD, founder of Holistic Business Risk, about a broader and more human view of risk manage...

LTR 157: Why Risk Doesn't Get Heard and How to Change That

May 29, 2026 7:00am 27 min

Summary“Quality and risk people need to translate safety into business terms.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eric Sugalski about how MedTech professionals can communicate safety, r...

LTR 156: Using AI as a Thinking Partner in Product Development Without Losing Control

May 22, 2026 7:00am 27 min

Summary“AI can be a powerful helper, but it should not be the decision-maker.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with David Grilli about how MedTech teams can use AI responsibly in product ...

LTR 155: Leverage VIP to Move from Compliance to Capability

May 15, 2026 8:00am 26 min

Summary“Compliance alone does not drive quality”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go b...

LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections

May 08, 2026 7:00am 38 min

Summary“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about wh...

LTR 153: Sherita Black on Building a Practical Policy for Risk Acceptability

May 01, 2026 7:00am 29 min

Summary“Just having a policy in place is one thing. Having a QMS that aligns to it is the next.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Sherita Black about one of the most challenging and o...

LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems

April 24, 2026 7:00am 36 min

Summary“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits do...

LTR 151: Sarai Pahla on Managing Supply Chain Disruption Risk in Life Sciences

April 17, 2026 7:00am 26 min

Summary“Loss of service or device is loss of benefit, which means it naturally increases the risk of our device.”What happens when a highly regulated medical device depends on a tiny, single-sourced component buried deep...

Case Study: How Patient Preference Data Rescued a High-Risk Device

April 10, 2026 7:00am 20 min

Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.If you ar...

LTR 150: Jonathan Kendler on Rethinking Human Factors Engineering for AI/ML-Enabled Devices

April 03, 2026 7:00am 29 min

Summary“AI brings novel risks and addressing them will require a more creative approach to human factors engineering.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Jonathan Kendler, a seasoned me...

LTR 149: Lavanya Ramnath on Risk Analysis, IDE Strategy, and Patient-Centered Design

March 27, 2026 7:00am 28 min

Summary“The clinical study is actually where your risk analysis is going to meet reality.”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Lavanya Ramnath, Senior Regulatory Affairs Specialist at In...

LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach

March 20, 2026 7:00am 29 min

Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape...

LTR 147: Richard Matt on Bringing Benefit–Risk Upstream in Design and Development

March 13, 2026 7:00am 26 min

Summary“Look at how benefits and risks are allocated among different design options and pick a product architecture that minimizes risks and maximizes benefits.”In this Let’s Talk Risk! conversation, Richard Matt shares ...

LTR 146: Ganesh Sabat on Scaling MedTech Through Quality

March 06, 2026 7:00am 25 min

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)...

LTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning

February 27, 2026 7:00am 28 min

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 pers...

LTR 144: Jean Blom on How Hazard-First Thinking Improves Risk Management

February 20, 2026 7:00am 28 min

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...

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