Global Medical Device Podcast powered by greenlight.guru

Implementing Changes to SaMD under New EU MDR

Episode 118

Listen to the Podcast

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

Listen to the Podcast

Right-sizing your QMS

Episode 116

Listen to the Podcast

Challenges with Pediatric Medical Devices

Episode 115

Listen to the Podcast

When Should You Start a QMS?

Episode 114

Listen to the Podcast

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

Listen to the Podcast

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

Listen to the Podcast

Importance of Software Requirements in Product Development

Episode 111

Listen to the Podcast

4 Facts That May Surprise You About FDA

Episode 110

Listen to the Podcast

Design History File Ready Ideation: An Innovative Approach To Product Development

Episode 109

Listen to the Podcast

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

Listen to the Podcast

Challenges with MedTech Innovation

Episode 107

Listen to the Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

Listen to the Podcast

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

Listen to the Podcast

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104

Listen to the Podcast

EU MDR: Not All Doom and Gloom

Episode 103

Listen to the Podcast

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

Listen to the Podcast

How to Make De Novo a Viable Option for your Medical Device

Episode 101

Listen to the Podcast

The 100th Episode: A Few of My Favorite Moments

Episode 100

Listen to the Podcast

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99

Listen to the Podcast

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Episode 98

Listen to the Podcast

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

Listen to the Podcast

Nonbinding Feedback is a New Guidance You Should Know About

Episode 96

Listen to the Podcast

How and When to Consider Human Factors

Episode 95

Listen to the Podcast

Who Should Own Your QMS?

Episode 94

Listen to the Podcast

Design Validation vs. Human Factors Validation

Episode 93

Listen to the Podcast

Medical Device Product Development Value Proposition

Episode 92

Listen to the Podcast

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

Listen to the Podcast

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Episode 90

Listen to the Podcast

Aligning True Quality and Compliance with MDDAP

Episode 89

Listen to the Podcast

Explaining the Significance of Voluntary Consensus Standards

Episode 88

Listen to the Podcast

Medical Device Industry Predictions for 2019

Episode 87

Listen to the Podcast

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

Episode 86

Listen to the Podcast

Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

Listen to the Podcast

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

Listen to the Podcast

Streamlining The Device Marketing Authorization Process

Episode 83

Listen to the Podcast

The New Special 510(k)

Episode 82

Listen to the Podcast

What's New With PMAs

Episode 81

Listen to the Podcast

How to Efficiently Raise Funds for Your Medical Device Company

Episode 80

Listen to the Podcast

7 Habits of Highly Effective True Quality Medical Device Professionals

Episode 79

Listen to the Podcast

Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

Listen to the Podcast

Questions to Ask Before Hiring Your Consultant

Episode 77

Listen to the Podcast

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

Episode 76

Listen to the Podcast

Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

Listen to the Podcast

15 Habits of Highly Effective Regulatory Professionals

Episode 74

Listen to the Podcast

How to Embrace Risk for Safer Devices

Episode 73

Listen to the Podcast

What you Need to know About FDA's Progressive Programs

Episode 72

Listen to the Podcast

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

Episode 71

Listen to the Podcast

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Episode 70

Listen to the Podcast

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

Episode 69

Listen to the Podcast

How Human Factors Impact Your Medical Device

Episode 68

Listen to the Podcast

How to Think About Quality and Regulatory as Your Company Scales

Episode 67

Listen to the Podcast

How to Design for Compliance with IEC60601

Episode 66

Listen to the Podcast

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

Episode 65

Listen to the Podcast

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

Episode 64

Listen to the Podcast

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

Episode 63

Listen to the Podcast

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

Episode 62

Listen to the Podcast

Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

Listen to the Podcast

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

Episode 60

Listen to the Podcast

5 Most Common Problems with Your CAPA System

Epsidoe 59

Listen to the Podcast

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

Episode 58

Listen to the Podcast

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

Episode 57

Listen to the Podcast

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

Episode 56

Listen to the Podcast

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

Episode 55

Listen to the Podcast

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

Listen to the Podcast

Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

Listen to the Podcast

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

Episode 52

Listen to the Podcast

Lessons to Be Learned From Recent FDA Inspections

Episode 51

Listen to the Podcast

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

Episode 50

Listen to the Podcast

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

Listen to the Podcast

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

Episode 48

Listen to the Podcast

How Process Excellence Leads to Product Excellence

Episode 47

Listen to the Podcast

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

Listen to the Podcast

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

Episode 45

Listen to the Podcast

Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

Listen to the Podcast

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

Episode 43

Listen to the Podcast

The Intersection of Medical Device Usability and Risk Management

Episode 42

Listen to the Podcast

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

Episode 41

Listen to the Podcast

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

Episode 40

Listen to the Podcast

An Overview of What Device Makers Need to Know About CAPA

Episode 39

Listen to the Podcast

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

Episode 38

Listen to the Podcast

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

Episode 37

Listen to the Podcast

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

Episode 36

Listen to the Podcast

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

Episode 35

Listen to the Podcast

2016 Medical Device Regulatory Trends Year in Review

Episode 34

Listen to the Podcast

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

Episode 33

Listen to the Podcast

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

Episode 32

Listen to the Podcast

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

Episode 31

Listen to the Podcast

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

Episode 30

Listen to the Podcast

What Device Makers Need To Know About The FDA Pre-Submission Process (Part Two)

Episode 29

Listen to the Podcast

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

Episode 28

Listen to the Podcast

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

Episode 27

Listen to the Podcast

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Episode 26

Listen to the Podcast

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

Episode 25

Listen to the Podcast

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

Episode 24

Listen to the Podcast

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

Episode 23

Listen to the Podcast

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

Episode 22

Listen to the Podcast

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

Episode 21

Listen to the Podcast

Tips to Help You Prepare for an FDA Inspection

Episode 20

Listen to the Podcast

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

Episode 19

Listen to the Podcast

Integrating Business Elements into Your Product Development Process with Therese Graff

Episode 18

Listen to the Podcast

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Episode 17

Listen to the Podcast

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

Episode 16

Listen to the Podcast

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

Episode 15

Listen to the Podcast

Medical Device Product Development Project Management Best Practices With Peter Sebelius

Episode 14

Listen to the Podcast

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

Episode 13

Listen to the Podcast

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

Episode 12

Listen to the Podcast

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

Episode 11

Listen to the Podcast

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

Episode 10

Listen to the Podcast

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

Episode 9

Listen to the Podcast

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

Episode 8

Listen to the Podcast

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

Episode 7

Listen to the Podcast

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

Episode 6

Listen to the Podcast

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

Episode 5

Listen to the Podcast

Risk Management from a Regulatory & Product Development Point of View

Episode 4

Listen to the Podcast

How to Improve Your Medical Device Design Reviews Bonus Episode

Episode 3 Plus

Listen to the Podcast

How To Improve Your Medical Device Design Reviews

Episode 3

Listen to the Podcast

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

Episode 2

Listen to the Podcast

Best Practices for Implementing Design Controls for the Medical Device Industry

Episode 1

Listen to the Podcast

Podcasts

The Global Medical Device Podcast

Catch Up On Recent Episodes

Implementing Changes to SaMD under New EU MDR

Career Tips for QA/RA Professionals in the Medical Device Industry

Right-sizing your QMS

Challenges with Pediatric Medical Devices

When Should You Start a QMS?

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Importance of Software Requirements in Product Development

4 Facts That May Surprise You About FDA

Design History File Ready Ideation: An Innovative Approach To Product Development

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Challenges with MedTech Innovation

Is Your Medical Device Company CAPA Happy?

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Greenlight Guru In the Classroom: A University's Real-world Approach

EU MDR: Not All Doom and Gloom

Biocompatibility Nuances and its Impact on Medical Devices

How to Make De Novo a Viable Option for your Medical Device

The 100th Episode: A Few of My Favorite Moments

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Nonbinding Feedback is a New Guidance You Should Know About

How and When to Consider Human Factors

Who Should Own Your QMS?

Design Validation vs. Human Factors Validation

Medical Device Product Development Value Proposition

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Aligning True Quality and Compliance with MDDAP

Explaining the Significance of Voluntary Consensus Standards

Medical Device Industry Predictions for 2019

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