The QMS conversation your clients are having without you
MLVx Friday In-Focus Calls
The QMS conversation your clients are having without you
48:33
First-in-Human Clinical Trials in Latin America, What MedTech Teams Need to Know Before They Expand
MLVx Friday In-Focus Calls
First-in-Human Clinical Trials in Latin America, What MedTech Teams Need to Know Before They Expand
49:55
AIML FDA Submissions common pitfalls, hard lessons, and faster paths forward
MLVx Friday In-Focus Calls
AIML FDA Submissions common pitfalls, hard lessons, and faster paths forward
57:31
Global Regulatory Submissions Made Simple
MLVx Friday In-Focus Calls
Global Regulatory Submissions Made Simple
58:00
PMCF Surveys Under MDRWhen They Apply, How to Structure Them, and WhatHigh-Quality Looks Like
MLVx Friday In-Focus Calls
PMCF Surveys Under MDRWhen They Apply, How to Structure Them, and WhatHigh-Quality Looks Like
52:38
Regulatory Intelligence Is Only the Start
MLVx Friday In-Focus Calls
Regulatory Intelligence Is Only the Start
55:17
AI System in Quality & Regulatory Affairs
MLVx Friday In-Focus Calls
AI System in Quality & Regulatory Affairs
53:42
AI in Regulatory Intelligence, Clinical Evaluation & PMS
MLVx Friday In-Focus Calls
AI in Regulatory Intelligence, Clinical Evaluation & PMS
57:47
Designing Better Formatives: Simulated Use, Realism, and the Risks of Playing It Safe
MLVx Friday In-Focus Calls
Designing Better Formatives: Simulated Use, Realism, and the Risks of Playing It Safe
53:11
AI for eSTAR: Faster FDA 510(k) Submissions
MLVx Friday In-Focus Calls
AI for eSTAR: Faster FDA 510(k) Submissions
1:01:51
The MedTech Employment Outlook for 2026 How AI is changing expectations, evaluation, and career
MLVx Friday In-Focus Calls
The MedTech Employment Outlook for 2026 How AI is changing expectations, evaluation, and career
59:30
MLV100 2026 Launch Party (AI Edition): Introducing the MLVx AI Platform
MLVx Friday In-Focus Calls
MLV100 2026 Launch Party (AI Edition): Introducing the MLVx AI Platform
1:04:17
RegTech 2026 in Medical Devices: Capabilities, Constraints & Human Oversight
MLVx Friday In-Focus Calls
RegTech 2026 in Medical Devices: Capabilities, Constraints & Human Oversight
59:08
The Anatomy of Connected Medical Devices: A Non-Technical Guide to the Ecosystem
MLVx Friday In-Focus Calls
The Anatomy of Connected Medical Devices: A Non-Technical Guide to the Ecosystem
1:04:52
When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026
MLVx Friday In-Focus Calls
When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026
1:01:13
Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026
MLVx Friday In-Focus Calls
Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026
1:00:17
2026 Cybersecurity Priorities for MedTech with Jose Bohorquez
MLVx Friday In-Focus Calls
2026 Cybersecurity Priorities for MedTech with Jose Bohorquez
57:23
IMDRF Initiatives: Driving Global Regulatory Harmonisation
MLVx Friday In-Focus Calls
IMDRF Initiatives: Driving Global Regulatory Harmonisation
1:02:19
MLVx 2026: The Year in Preview with Sean Smith
MLVx Friday In-Focus Calls
MLVx 2026: The Year in Preview with Sean Smith
1:01:12
Honing Your MedTech Message: How to Be Memorable in Two Minutes with Tino Chow
MLVx Friday In-Focus Calls
Honing Your MedTech Message: How to Be Memorable in Two Minutes with Tino Chow
1:05:38
Integrating Human Factors into the Quality System (QMS)
MLVx Friday In-Focus Calls
Integrating Human Factors into the Quality System (QMS)
1:04:08
Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value?
MLVx Friday In-Focus Calls
Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value?
1:04:50
Patient Safety 2026: Inside the International MedTech Safety Conference
MLVx Friday In-Focus Calls
Patient Safety 2026: Inside the International MedTech Safety Conference
1:03:31
The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up and What to Do Next
MLVx Friday In-Focus Calls
The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up and What to Do Next
1:01:47
Inside Brazil’s MedTech Market: What Global Companies Need to Know
MLVx Friday In-Focus Calls
Inside Brazil’s MedTech Market: What Global Companies Need to Know
1:03:48
AI for Regulatory Affairs: Unlocking Insights from Unstructured Data
MLVx Friday In-Focus Calls
AI for Regulatory Affairs: Unlocking Insights from Unstructured Data
1:10:28
CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC
MLVx Friday In-Focus Calls
CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC
1:00:26
MLVx 2026
MLVx Friday In-Focus Calls
MLVx 2026
1:10:31
Insights from the Portugal Unconference with Miguel Amador
MLVx Friday In-Focus Calls
Insights from the Portugal Unconference with Miguel Amador
52:27
Human Factors Engineering in MedTech: Why Usability Matters From Day One | Kay Sim
MLVx Friday In-Focus Calls
Human Factors Engineering in MedTech: Why Usability Matters From Day One | Kay Sim
55:17
Smart RAQA Compliance for a Shifting Future | Marcus Emne
MLVx Friday In-Focus Calls
Smart RAQA Compliance for a Shifting Future | Marcus Emne
1:01:48
Closing the Blind Spots: Designing Devices for the Real World
MLVx Friday In-Focus Calls
Closing the Blind Spots: Designing Devices for the Real World
1:00:11
Electronic Instructions for Use: Capitalizing on the EU’s eIFU Rollout | Michael Kania (Meddevo)
MLVx Friday In-Focus Calls
Electronic Instructions for Use: Capitalizing on the EU’s eIFU Rollout | Michael Kania (Meddevo)
48:12
Take Advantage of Canada – Practical Insights for MedTech Market Access | In-Focus Replay
MLVx Friday In-Focus Calls
Take Advantage of Canada – Practical Insights for MedTech Market Access | In-Focus Replay
31:21
AI for Regulatory Affairs - Practical Strategies and Case Studies | In-Focus Replay
MLVx Friday In-Focus Calls
AI for Regulatory Affairs - Practical Strategies and Case Studies | In-Focus Replay
42:45
FDA Pre-Submissions, Inherent Use, and Regulatory Trends – Strategies for MedTech | In-Focus Replay
MLVx Friday In-Focus Calls
FDA Pre-Submissions, Inherent Use, and Regulatory Trends – Strategies for MedTech | In-Focus Replay
46:24
IEC 60601 4th Edition – What MedTech Manufacturers Need to Know Now | In-Focus Replay
MLVx Friday In-Focus Calls
IEC 60601 4th Edition – What MedTech Manufacturers Need to Know Now | In-Focus Replay
53:53
From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay
MLVx Friday In-Focus Calls
From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay
57:44
How Much Does a QMS Really Cost? Real-World Startup Lessons from a Fractional Expert | In-Focus
MLVx Friday In-Focus Calls
How Much Does a QMS Really Cost? Real-World Startup Lessons from a Fractional Expert | In-Focus
54:52
Cybersecurity for Medical Devices – FDA 510(k) Cyberecurity Compliance | In-Focus
MLVx Friday In-Focus Calls
Cybersecurity for Medical Devices – FDA 510(k) Cyberecurity Compliance | In-Focus
57:13
PRRC Role Demystified – Legal Risk, Strategy & Leadership for EU MDR | In-Focus Replay
MLVx Friday In-Focus Calls
PRRC Role Demystified – Legal Risk, Strategy & Leadership for EU MDR | In-Focus Replay
46:56
Digital Transformation for MedTech Compliance – MDR Pain Points to Scalable AI | Friday In-Focus
MLVx Friday In-Focus Calls
Digital Transformation for MedTech Compliance – MDR Pain Points to Scalable AI | Friday In-Focus
56:03
Clinical Evaluation Pathways for CE Marking w/Steffen Ruschinski
MLVx Friday In-Focus Calls
Clinical Evaluation Pathways for CE Marking w/Steffen Ruschinski
47:52
Digital Marketing for OEMs and CMOs w/Elvio Gramignano
MLVx Friday In-Focus Calls
Digital Marketing for OEMs and CMOs w/Elvio Gramignano
58:55
MLVx Masterclass - A Roadmap to High-Value Client Acquisition
MLVx Friday In-Focus Calls
MLVx Masterclass - A Roadmap to High-Value Client Acquisition
57:53
Leading Teams Through Change – Trust, Silos, and EQ in Big MedTech | In-Focus Replay
MLVx Friday In-Focus Calls
Leading Teams Through Change – Trust, Silos, and EQ in Big MedTech | In-Focus Replay
50:52
Protecting MedTech Innovation: AI Tools for Smarter Patents w/Ignacio Smet
MLVx Friday In-Focus Calls
Protecting MedTech Innovation: AI Tools for Smarter Patents w/Ignacio Smet
54:31
Tackling Today's BIGGEST Regulatory Challenges w/Adam Isaacs Rae
MLVx Friday In-Focus Calls
Tackling Today's BIGGEST Regulatory Challenges w/Adam Isaacs Rae
1:00:38
NEW AI Model Builder For Regulatory | Labrynth.ai
MLVx Friday In-Focus Calls
NEW AI Model Builder For Regulatory | Labrynth.ai
53:41