MLVx Friday In-Focus Calls

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MedTech Leading Voice Exchange (MLVx) | Free weekly Friday In-Focus Calls | Featuring new expert MedTech speakers every week in an interactive panel discussion. Formerly MDG Premium, hosted by Joe Hage. As of May 2025, hosted by Sean Smith, publisher of MedTech Leading Voice.

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Global Regulatory Submissions Made Simple

Global Regulatory Submissions Made Simple MLVx Friday In-Focus Calls

15 views - 1 day ago

PMCF Surveys Under MDRWhen They Apply, How to Structure Them, and WhatHigh-Quality Looks Like

PMCF Surveys Under MDRWhen They Apply, How to Structure Them, and WhatHigh-Quality Looks Like MLVx Friday In-Focus Calls

26 views - 1 week ago

Regulatory Intelligence Is Only the Start

Regulatory Intelligence Is Only the Start MLVx Friday In-Focus Calls

14 views - 2 weeks ago

AI System in Quality & Regulatory Affairs

AI System in Quality & Regulatory Affairs MLVx Friday In-Focus Calls

34 views - 3 weeks ago

AI in Regulatory Intelligence, Clinical Evaluation & PMS

AI in Regulatory Intelligence, Clinical Evaluation & PMS MLVx Friday In-Focus Calls

21 views - 4 weeks ago

Designing Better Formatives: Simulated Use, Realism, and the Risks of Playing It Safe

Designing Better Formatives: Simulated Use, Realism, and the Risks of Playing It Safe MLVx Friday In-Focus Calls

13 views - 1 month ago

AI for eSTAR: Faster FDA 510(k) Submissions

AI for eSTAR: Faster FDA 510(k) Submissions MLVx Friday In-Focus Calls

26 views - 1 month ago

The MedTech Employment Outlook for 2026 How AI is changing expectations, evaluation, and career

The MedTech Employment Outlook for 2026 How AI is changing expectations, evaluation, and career MLVx Friday In-Focus Calls

37 views - 1 month ago

MLV100 2026 Launch Party (AI Edition): Introducing the MLVx AI Platform

MLV100 2026 Launch Party (AI Edition): Introducing the MLVx AI Platform MLVx Friday In-Focus Calls

20 views - 1 month ago

RegTech 2026 in Medical Devices: Capabilities, Constraints & Human Oversight

RegTech 2026 in Medical Devices: Capabilities, Constraints & Human Oversight MLVx Friday In-Focus Calls

17 views - 1 month ago

The Anatomy of Connected Medical Devices: A Non-Technical Guide to the Ecosystem

The Anatomy of Connected Medical Devices: A Non-Technical Guide to the Ecosystem MLVx Friday In-Focus Calls

25 views - 1 month ago

When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026

When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026 MLVx Friday In-Focus Calls

83 views - 1 month ago

Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026

Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026 MLVx Friday In-Focus Calls

35 views - 1 month ago

2026 Cybersecurity Priorities for MedTech with Jose Bohorquez

2026 Cybersecurity Priorities for MedTech with Jose Bohorquez MLVx Friday In-Focus Calls

49 views - 3 months ago

IMDRF Initiatives: Driving Global Regulatory Harmonisation

IMDRF Initiatives: Driving Global Regulatory Harmonisation MLVx Friday In-Focus Calls

28 views - 3 months ago

MLVx 2026: The Year in Preview with Sean Smith

MLVx 2026: The Year in Preview with Sean Smith MLVx Friday In-Focus Calls

26 views - 3 months ago

Honing Your MedTech Message: How to Be Memorable in Two Minutes with Tino Chow

Honing Your MedTech Message: How to Be Memorable in Two Minutes with Tino Chow MLVx Friday In-Focus Calls

18 views - 3 months ago

Integrating Human Factors into the Quality System (QMS)

Integrating Human Factors into the Quality System (QMS) MLVx Friday In-Focus Calls

52 views - 4 months ago

Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value?

Lead Auditors: You Need Them, but Can You Guarantee They Really Add Value? MLVx Friday In-Focus Calls

21 views - 4 months ago

Patient Safety 2026: Inside the International MedTech Safety Conference

Patient Safety 2026: Inside the International MedTech Safety Conference MLVx Friday In-Focus Calls

20 views - 4 months ago

The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up and What to Do Next

The Five Biggest Stumbling Blocks Small Device Teams Hit in Study Start-Up and What to Do Next MLVx Friday In-Focus Calls

44 views - 5 months ago

Inside Brazil’s MedTech Market: What Global Companies Need to Know

Inside Brazil’s MedTech Market: What Global Companies Need to Know MLVx Friday In-Focus Calls

26 views - 5 months ago

AI for Regulatory Affairs: Unlocking Insights from Unstructured Data

AI for Regulatory Affairs: Unlocking Insights from Unstructured Data MLVx Friday In-Focus Calls

99 views - 5 months ago

CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC

CREATE on AI for Regulatory Affairs + Live from Rome with Team PRRC MLVx Friday In-Focus Calls

56 views - 5 months ago

MLVx 2026 MLVx Friday In-Focus Calls

96 views - 6 months ago

Insights from the Portugal Unconference with Miguel Amador

Insights from the Portugal Unconference with Miguel Amador MLVx Friday In-Focus Calls

26 views - 6 months ago

Human Factors Engineering in MedTech: Why Usability Matters From Day One | Kay Sim

Human Factors Engineering in MedTech: Why Usability Matters From Day One | Kay Sim MLVx Friday In-Focus Calls

60 views - 6 months ago

Smart RAQA Compliance for a Shifting Future | Marcus Emne

Smart RAQA Compliance for a Shifting Future | Marcus Emne MLVx Friday In-Focus Calls

45 views - 7 months ago

Closing the Blind Spots: Designing Devices for the Real World

Closing the Blind Spots: Designing Devices for the Real World MLVx Friday In-Focus Calls

12 views - 7 months ago

Electronic Instructions for Use: Capitalizing on the EU’s eIFU Rollout | Michael Kania (Meddevo)

Electronic Instructions for Use: Capitalizing on the EU’s eIFU Rollout | Michael Kania (Meddevo) MLVx Friday In-Focus Calls

93 views - 7 months ago

Take Advantage of Canada – Practical Insights for MedTech Market Access | In-Focus Replay

Take Advantage of Canada – Practical Insights for MedTech Market Access | In-Focus Replay MLVx Friday In-Focus Calls

42 views - 7 months ago

AI for Regulatory Affairs - Practical Strategies and Case Studies | In-Focus Replay

AI for Regulatory Affairs - Practical Strategies and Case Studies | In-Focus Replay MLVx Friday In-Focus Calls

446 views - 7 months ago

FDA Pre-Submissions, Inherent Use, and Regulatory Trends – Strategies for MedTech | In-Focus Replay

FDA Pre-Submissions, Inherent Use, and Regulatory Trends – Strategies for MedTech | In-Focus Replay MLVx Friday In-Focus Calls

92 views - 7 months ago

IEC 60601 4th Edition – What MedTech Manufacturers Need to Know Now | In-Focus Replay

IEC 60601 4th Edition – What MedTech Manufacturers Need to Know Now | In-Focus Replay MLVx Friday In-Focus Calls

555 views - 8 months ago

From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay

From Documents to Digital Knowledge – How MedTech Can Future-Proof Compliance | In-Focus Replay MLVx Friday In-Focus Calls

51 views - 8 months ago

How Much Does a QMS Really Cost? Real-World Startup Lessons from a Fractional Expert | In-Focus

How Much Does a QMS Really Cost? Real-World Startup Lessons from a Fractional Expert | In-Focus MLVx Friday In-Focus Calls

31 views - 8 months ago

Cybersecurity for Medical Devices – FDA 510(k) Cyberecurity Compliance | In-Focus

Cybersecurity for Medical Devices – FDA 510(k) Cyberecurity Compliance | In-Focus MLVx Friday In-Focus Calls

182 views - 8 months ago

PRRC Role Demystified – Legal Risk, Strategy & Leadership for EU MDR | In-Focus Replay

PRRC Role Demystified – Legal Risk, Strategy & Leadership for EU MDR | In-Focus Replay MLVx Friday In-Focus Calls

70 views - 9 months ago

Digital Transformation for MedTech Compliance – MDR Pain Points to Scalable AI | Friday In-Focus

Digital Transformation for MedTech Compliance – MDR Pain Points to Scalable AI | Friday In-Focus MLVx Friday In-Focus Calls

37 views - 9 months ago

Clinical Evaluation Pathways for CE Marking w/Steffen Ruschinski

Clinical Evaluation Pathways for CE Marking w/Steffen Ruschinski MLVx Friday In-Focus Calls

95 views - 9 months ago

Digital Marketing for OEMs and CMOs w/Elvio Gramignano

Digital Marketing for OEMs and CMOs w/Elvio Gramignano MLVx Friday In-Focus Calls

25 views - 9 months ago

MLVx Masterclass - A Roadmap to High-Value Client Acquisition

MLVx Masterclass - A Roadmap to High-Value Client Acquisition MLVx Friday In-Focus Calls

73 views - 10 months ago

Leading Teams Through Change – Trust, Silos, and EQ in Big MedTech | In-Focus Replay

Leading Teams Through Change – Trust, Silos, and EQ in Big MedTech | In-Focus Replay MLVx Friday In-Focus Calls

35 views - 10 months ago

Protecting MedTech Innovation: AI Tools for Smarter Patents w/Ignacio Smet

Protecting MedTech Innovation: AI Tools for Smarter Patents w/Ignacio Smet MLVx Friday In-Focus Calls

15 views - 10 months ago

Tackling Today's BIGGEST Regulatory Challenges w/Adam Isaacs Rae

Tackling Today's BIGGEST Regulatory Challenges w/Adam Isaacs Rae MLVx Friday In-Focus Calls

17 views - 10 months ago

NEW AI Model Builder For Regulatory | Labrynth.ai

NEW AI Model Builder For Regulatory | Labrynth.ai MLVx Friday In-Focus Calls

60 views - 10 months ago