Global Medical Device Podcast powered by greenlight.guru

What is a Multiple Function Device?

Episode 164

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Challenges related to Home Use Devices

Episode 163

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Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

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How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

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Meet a Guru: Wade Schroeder

Episode 160

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What are the Audit Etiquette Rules I Should be Following?

Episode 159

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Meet a Guru: Tom Rish

Episode 158

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Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

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Protecting the Intellectual Property of your Medical Device Technology

Episode 156

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Meet a Guru: Jesseca Lyons

Episode 155

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How to Build a QMS for a Medical Device

Episode 154

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Meet a Guru: Taylor Brown

Episode 153

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What is Regulatory Due Diligence for Medical Devices?

Episode 152

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Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

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How Being Strategic During A Career Transition Can Yield The Best Opportunities

Episode 150

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Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Episode 149

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How to Construct an Effective Regulatory Strategy

Episode 148

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What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Episode 147

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How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Episode 146

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510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

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Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Episode 144

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[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

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How to Approach Verification and Validation for Cloud Software

Episode 142

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Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Episode 141

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Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

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How to Integrate Usability into your Medical Device

Episode 139

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[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

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How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

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How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

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How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Episode 134

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4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

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5 Tips for Hiring Medical Device Advisors

Episode 132

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2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

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Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

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What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

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5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

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How to Solve the Medtech Value Equation with Quality Data

Episode 127

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Why Supplier Quality Management Is So Important

Episode 126

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FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

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Preparing for EU MDR

Episode 124

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Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

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Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

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Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

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Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

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Challenges with Pediatric Medical Devices

Episode 119

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Implementing Changes to SaMD under New EU MDR

Episode 118

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

Episode 117

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Right-sizing your QMS

Episode 116

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Challenges with Pediatric Medical Devices

Episode 115

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When Should You Start a QMS?

Episode 114

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

Episode 113

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

Episode 112

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Importance of Software Requirements in Product Development

Episode 111

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4 Facts That May Surprise You About FDA

Episode 110

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

Episode 109

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

Episode 108

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Challenges with MedTech Innovation

Episode 107

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Is Your Medical Device Company CAPA Happy?

Episode 106

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Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

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

Episode 104

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EU MDR: Not All Doom and Gloom

Episode 103

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Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

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

Episode 101

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The 100th Episode: A Few of My Favorite Moments

Episode 100

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

Episode 99

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

Episode 98

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

Episode 97

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Nonbinding Feedback is a New Guidance You Should Know About

Episode 96

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How and When to Consider Human Factors

Episode 95

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Who Should Own Your QMS?

Episode 94

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Design Validation vs. Human Factors Validation

Episode 93

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Medical Device Product Development Value Proposition

Episode 92

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Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

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

Episode 90

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Aligning True Quality and Compliance with MDDAP

Episode 89

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Explaining the Significance of Voluntary Consensus Standards

Episode 88

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Medical Device Industry Predictions for 2019

Episode 87

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

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

What is a Multiple Function Device?

Challenges related to Home Use Devices

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

How Jon Speer Met His Most Frequent Guest: Mike Drues

Meet a Guru: Wade Schroeder

What are the Audit Etiquette Rules I Should be Following?

Meet a Guru: Tom Rish

Addressing Clinical Trial Challenges & Concerns during COVID-19

Protecting the Intellectual Property of your Medical Device Technology

Meet a Guru: Jesseca Lyons

How to Build a QMS for a Medical Device

Meet a Guru: Taylor Brown

What is Regulatory Due Diligence for Medical Devices?

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

How Being Strategic During A Career Transition Can Yield The Best Opportunities

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

How to Construct an Effective Regulatory Strategy

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

How to Approach Verification and Validation for Cloud Software

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

How to Integrate Usability into your Medical Device

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

How to Leverage IEC 62304 to Improve SaMD Development Processes

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

How to Choose the Right FDA Regulatory Pathway for your Device

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

4 Parts to Interviewing Candidates for Medical Device Roles

5 Tips for Hiring Medical Device Advisors

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Navigating the Twists and Turns of Change Management for Medical Devices

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

5 Myths about QA/RA Recruiting in the Medical Device Industry

How to Solve the Medtech Value Equation with Quality Data

Why Supplier Quality Management Is So Important

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Preparing for EU MDR

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Challenges with Pediatric Medical Devices

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