Global Medical Device Podcast powered by greenlight.guru

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

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Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

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Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

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Streamlining The Device Marketing Authorization Process

Episode 83

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The New Special 510(k)

Episode 82

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What's New With PMAs

Episode 81

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How to Efficiently Raise Funds for Your Medical Device Company

Episode 80

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7 Habits of Highly Effective True Quality Medical Device Professionals

Episode 79

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Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

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Questions to Ask Before Hiring Your Consultant

Episode 77

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What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76

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Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

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15 Habits of Highly Effective Regulatory Professionals

Episode 74

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How to Embrace Risk for Safer Devices

Episode 73

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What you Need to know About FDA's Progressive Programs

Episode 72

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What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Episode 71

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The Bleeding Edge: Lessons Learned for the Medical Device Industry

Episode 70

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AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Episode 69

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How Human Factors Impact Your Medical Device

Episode 68

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How to Think About Quality and Regulatory as Your Company Scales

Episode 67

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How to Design for Compliance with IEC60601

Episode 66

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FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

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How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

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Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

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Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Episode 62

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Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

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How to Ensure Your Quality Management System is Effective and Benefits Patients

Episode 60

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5 Most Common Problems with Your CAPA System

Epsidoe 59

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How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Episode 58

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What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Episode 57

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Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56

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An Overview of What Medical Device Developers Need to Know About Human Factors

Episode 55

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Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

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Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

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How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

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Lessons to Be Learned From Recent FDA Inspections

Episode 51

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Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

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How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

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Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

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How Process Excellence Leads to Product Excellence

Episode 47

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Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

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Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Episode 45

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Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

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When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

Episode 43

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The Intersection of Medical Device Usability and Risk Management

Episode 42

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How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

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How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

Episode 40

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An Overview of What Device Makers Need to Know About CAPA

Episode 39

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How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Episode 38

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Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Episode 37

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What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

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How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

Episode 35

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2016 Medical Device Regulatory Trends Year in Review

Episode 34

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Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Episode 33

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Tips for Success When It Comes to IEC 60601 with Leo Eisner

Episode 32

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Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

Episode 31

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Understanding the New FDA Guidance on Changes to 510(k)

Episode 30

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Understanding the New FDA Guidance on Changes to 510(k)

Episode 29

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Preparing for the Changes to the EU Medical Device and In-Vitro Diagnostics Regulations

Episode 28

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Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Episode 27

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Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Episode 26

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How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Episode 25

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Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Episode 24

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Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Episode 23

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Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Episode 22

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Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

Episode 21

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Tips to Help You Prepare for an FDA Inspection

Episode 20

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What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Episode 19

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Integrating Business Elements into Your Product Development Process with Therese Graff

Episode 18

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How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Episode 17

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The Difference Between Intended Use and Indications of Use with Mike Drues

Episode 16

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Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Episode 15

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Medical Device Product Development Project Management Best Practices With Peter Sebelius

Episode 14

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Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Episode 13

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An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

Episode 12

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Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Episode 11

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Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

Episode 10

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How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

Episode 9

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How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

Episode 8

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Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

Episode 7

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How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

Episode 6

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Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Episode 5

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Risk Management from a Regulatory & Product Development Point of View

Episode 4

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How to Improve Your Medical Device Design Reviews Bonus Episode

Episode 3 Plus

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How To Improve Your Medical Device Design Reviews

Episode 3

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Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Episode 2

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Best Practices for Implementing Design Controls for the Medical Device Industry

Episode 1

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Podcasts

The Global Medical Device Podcast

Catch Up On Recent Episodes

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Understanding the Blurred Lines Between Consumer Tech and MedTech

Understanding The Differences Between Clearance vs Approval vs Granted

Streamlining The Device Marketing Authorization Process

The New Special 510(k)

What's New With PMAs

How to Efficiently Raise Funds for Your Medical Device Company

7 Habits of Highly Effective True Quality Medical Device Professionals

Regulatory Tips & Observations from a Former FDA Reviewer

Questions to Ask Before Hiring Your Consultant

What You Need to Know About The FDA CDRH Experiential Learning Program

Latest Updates on CDRH Standards Program and IEC 60601

15 Habits of Highly Effective Regulatory Professionals

How to Embrace Risk for Safer Devices

What you Need to know About FDA's Progressive Programs

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

The Bleeding Edge: Lessons Learned for the Medical Device Industry

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

How Human Factors Impact Your Medical Device

How to Think About Quality and Regulatory as Your Company Scales

How to Design for Compliance with IEC60601

FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Helping to Prepare Biomedical Engineers Entering the Workforce

How to Ensure Your Quality Management System is Effective and Benefits Patients

5 Most Common Problems with Your CAPA System

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

An Overview of What Medical Device Developers Need to Know About Human Factors

Challenges with Applying Risk Management Throughout the Manufacturing Process

Common Mistakes That Can Tank Your 510(k) Submission

How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Lessons to Be Learned From Recent FDA Inspections

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

How Process Excellence Leads to Product Excellence

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Understanding the Connection Between Complaints, CAPAs, and MDRs

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

The Intersection of Medical Device Usability and Risk Management

How FDA Interacts with Medical Devices When They Are Imported into the US

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

An Overview of What Device Makers Need to Know About CAPA

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

What Devicemakers Need to Know About Medical Device Reporting (MDR)

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

2016 Medical Device Regulatory Trends Year in Review

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

Understanding the New FDA Guidance on Changes to 510(k)

Understanding the New FDA Guidance on Changes to 510(k)

Preparing for the Changes to the EU Medical Device and In-Vitro Diagnostics Regulations

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

Tips to Help You Prepare for an FDA Inspection

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Integrating Business Elements into Your Product Development Process with Therese Graff

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

The Difference Between Intended Use and Indications of Use with Mike Drues

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Medical Device Product Development Project Management Best Practices With Peter Sebelius

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey