Greenlight Guru: Podcast

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How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

CAPA Process Mistakes You Want to Avoid

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

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

Advancing MRI Technology As We Know It Today

Improving the Colon Cancer Screening Experience

Creating a Culture of Quality for Medical Device Companies

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

Implementing Changes to SaMD under New EU MDR

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

How to Leverage IEC 62304 to improve SaMD Development Processes

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

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

Meet a Guru: Erica Loring

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

What are the Strategic Priorities for CDRH in 2021?

Everything you Need to Know about SaMD from an FDA Perspective

Meet a Guru: Karen Schuyler

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Meet a Guru: Ryan Behringer

Approaching Cybersecurity & Usability as a SaMD Company

Shifting Sands of SaMD Cybersecurity Regulations

Digitizing your SaMD Testing

Common QMS Mistakes SaMD Companies Make

The Best of Jon & Mike Through the Years

Ad Promo and The Difference in Regulatory & Legal

Cybersecurity and the Future of MedTech

Leaning into Lean Documentation

The Combination Products Handbook

Management Responsibility: The most important part of a QMS

CSA vs. CSV: Modern Validation for Modern MedTech

Understanding the ROI of an eQMS

The Role of dFMEA in Risk Management for Medical Devices

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

The Right Way to Start a QMS: When, How, & What

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

28 Days To Save The World - True Quality Roadshow

Regulatory Strategy and the Advantage of Diversity in MedTech

Exploring Breakthrough Device Designation

MedTech Funding and Preparing for Due Diligence

Accelerating SaMD Development in a Compliant Agile Way

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Selecting a Site for Your Clinical Trial

UDI and EUDAMED: Past, Present and Future State

Understanding LDTs & the FDA Proposed Ruling

What NOT to say to FDA

Planning an FDA Submission

Recent FDA Draft Guidances

Becoming an Advisor to a Medical Device Company

Using AI in MedTech

FDA's eSTAR Program

Human-Centered Design in Medical Devices

Considerations for IVD

Climbing the MedTech Career Ladder - How to Get to the Top

The Evolving Landscape of AI in MedTech

The State of AI & Clinical Investigations

Fundamentals of Quality & Regulatory

How Artificial Intelligence is Impacting the MedTech Industry

Becoming a MedTech Regulatory Affairs Professional

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

Interviewing the Interviewer

Obtaining Institutional Review Board (IRB) Approval

Advice to Medical Device Inventors

Meet a Guru: Jamie Bihary

Achieving ISO 13485 Certification

Getting Hired In MedTech

Creative Clinical Recruitment

Clinical Evidence: The Key to Market Adoption

UDI: 101

Understanding the 'Compliance Manager' Role

The Importance of Cervical Cancer Screening in the U.S.

When to Throw the Least Burdensome Flag on FDA

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

7 Habits of Highly Effective True Quality Medical Device Professionals

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

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

Why Building Supplier Relationships Is So Important

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

When Should You Start a QMS?

Best Practices for Clinical Evidence Management

Pros & Cons of Being a Physician turned MedTech Inventor

The Tools that Make Clinical Investigations

Preparing Your Pre-Submission with the Content FDA Wants to See

Auditing the Auditor

Regulatory Tips & Observations from a Former FDA Reviewer

Biocompatibility Nuances and its Impact on Medical Devices

Right-sizing your QMS

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

Understanding FDA's New Intended Use Rule and its Implications

Explaining the Role of Importer under EU MDR

What you Need to Know about FDA's Progressive Programs

Streamlining The Device Marketing Authorization Process

How to Construct an Effective Regulatory Strategy

Helping Prepare Biomedical Engineers Entering the Workforce

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

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

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Understanding and Handling Different Types of Feedback

Building Your Design Controls (and Pitfalls to Avoid)

Tips for Running Better Management Reviews

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

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Understanding the Blurred Lines Between Consumer Tech and MedTech

How AI Can Help You Manage Risk

Nonbinding Feedback is a New Guidance You Should Know About

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

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

Setting the Record Straight on Usability & Human Factors

Tips for Being Prepared Post-EUA (Emergency Use Authorization)

Why Supplier Quality Management Is So Important For Medical Device Companies

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Understanding the Connection Between Complaints, CAPAs, and MDRs

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

3 Systems of Risk for Medical Devices from FDA

How to Think About Quality and Regulatory as Your Company Scales

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

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

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

Quality Myths and Lessons Learned

UDI and the Current State of Global Implementation

What "Exempt" Means with Respect to Medical Devices & Regulatory

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

5 Tips for Hiring Medical Device Advisors

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

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

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

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

15 Habits of Highly Effective Regulatory Professionals

Regulatory Tips & Pointers from a Former FDA Reviewer

How to Efficiently Raise Funds for Your Medical Device Company

How to Improve Your Medical Device Design Reviews Bonus Episode

4 Facts That May Surprise You About FDA

Avoiding Potential Issues with your 510(k) Submission

What are the Opportunities for Improvement (OFI) for Quality?

Building a Culture of Quality

Meet a Guru: Laura Court

Design Validation vs. Human Factors Validation

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Assessing the Global Regulatory Landscape

Meet a Guru: Brittani Smith

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

Customer Discovery for Medical Device Companies

The Future of Lateral Flow Test Technology

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

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

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

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

Understanding FDA’s Proposed Conformity Assessment Pilot Program

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

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

Part 1: The Theranos Loophole & Lab Developed Tests

Bringing Medical Devices into the Home

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

A Regulatory Gap Analysis of FDA's Systems & Policies

Understanding the Value of a Medical Device Guru

Knowing vs. Doing as Medical Device Professionals

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Meet a GURU: Jesseca Lyons

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

Building a Startup in the MedTech Industry

Does Your CAPA Process Need a CAPA?

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

A Breakthrough Device that Aims to Prevent Osteoporosis

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

How To Improve Your Medical Device Design Reviews

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

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

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

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

How to Choose the Right FDA Regulatory Pathway for your Device

Pivoting Operations to Meet PPE Demand during Pandemic

Medical Device Industry Predictions for 2019

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

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

eQMS in Academia: Practical Learning for Biomedical Engineering Students

CDRH Proposed Guidance for FY 2023

Guerilla Tactics for Quality Leadership

Why Usability Matters

Addressing Clinical Trial Challenges & Concerns during COVID-19

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

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

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

How and When to Consider Human Factors

Quality Management for IVD Devices vs Medical Devices

For the Love of Internal Auditing

How does EU MDR impact your Quality Management System?

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

What is a Multiple Function Device?

Is Your Medical Device Company CAPA Happy?

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

Building Your Regulatory Strategy for Commercialization

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

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

How to Solve the Medtech Value Equation with Quality Data

Preparing for Remote and On-Site Inspections and Audits

Peeling back the Layers of HHS Proposal for 510(k) Exemptions

What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?

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

What are the Audit Etiquette Rules I Should be Following?

Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care

Positive and Negative Impacts of EUA on the Medical Device Industry

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

How to Integrate Usability into your Medical Device

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

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Why Design Verification Matters in Medical Device Design and Development

Navigating the MedTech Cybersecurity Ecosystem

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

What are the Strategic Priorities for CDRH in 2021?

What Goes into Designing Devices for Military and Emergency Applications?

Medical Device Product Development Value Proposition

Meet a Guru: Taylor Brown

Virtual Auditing in a Post-COVID World of Digital Compliance

Integrating Human Factors into Design Controls to Improve Patient Outcomes

An Overview of What Device Makers Need to Know About CAPA

Waterfall vs. Agile: Battle of the Product Development Methodologies

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

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

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

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Best Practices for Implementing Design Controls for the Medical Device Industry

Understanding the Investigational Device Exemption (IDE) Process

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

Human Factors & Risk Management: What's Needed & Why?

The Future of Cybersecurity

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

4 Parts to Interviewing Candidates for Medical Device Roles

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

Most Common Problems Found During FDA Inspections in 2022

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

The Future of Healthcare & How We Get There

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

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Complaint Handling with Medical Device Guru, Brittney McIver

How Augmented Reality (AR) is Revolutionizing Healthcare

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

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

Tips to Help You Prepare for an FDA Inspection

What is MedTech Lifecycle Excellence?

The Changing Job Market & How It Affects Careers for MedTech Quality Professionals

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Meet a Guru: Etienne Nichols

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

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

Meet a Guru: Wade Schroeder

Challenges with Applying Risk Management Throughout the Manufacturing Process

Design Assurance: The Unsung Heroes of R&D

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

How to Design for Compliance with IEC 60601

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

The 100th Episode: A Few of My Favorite Moments

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Navigating the Medical Device Single Audit Program (MDSAP)

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Building your Brand as a Medical Device Professional

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

How Medical Device Intellectual Property Protection Varies by Sector

Importance of Software Requirements in Product Development

How Communication Affects the Outcomes of Quality Activities

Making Your Informational Meetings with FDA Valuable & Worthwhile

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

How Mindset Training Can Help Your Team Operate at Peak Performance

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Lessons to Be Learned From Recent FDA Inspections

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

How Jon Speer Met His Most Frequent Guest: Mike Drues

Bridging the Gap between Medical Devices and Clinical Data

Early Feasibility Studies in Latin America

The New Special 510(k)

How Human Factors Impact Your Medical Device

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

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

Risk Management from a Regulatory & Product Development Point of View

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Achieving Operational Readiness through Good Project Management

Explaining the Significance of Voluntary Consensus Standards

How Process Excellence Leads to Product Excellence

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

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

Why the PMA Process is so Dreaded by Manufacturers in the US Market

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Why Biocompatibility Should be Addressed by Every Medical Device Company

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Developing a Regulatory Strategy

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

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

Managing Business Risk as a Medical Device Company

Essentials of Sterilization for Med Device Professionals

Part 2: The Theranos Loophole & Lab Developed Tests

We Achieved ISO Certification! Now What?

How to Select a Contract Manufacturer

Managing Clinical Data Activities

Preparing for EU MDR

How to Embrace Risk for Safer Devices

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

Medical Device Product Development Project Management Best Practices with Peter Sebelius

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

Meet a Guru: Tom Rish

EUA and the Impending Transition

Understanding the UDI System for Medical Devices

Overcoming Submission Deficiencies due to Biocompatibility

Why Storytelling Matters for Medical Device Companies

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Examining the HHS Proposal for Premarket Notification Exemptions

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

Packaging Validation Best Practices

EU MDR: Not All Doom and Gloom

Challenges with Pediatric Medical Devices

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

Challenges with MedTech Innovation

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Challenges for Regulatory Submission: EU vs. US

Common Mistakes That Can Tank Your FDA 510(k) Submission

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

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

Aligning True Quality and Compliance with MDDAP

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

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

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

Protecting the Intellectual Property of your Medical Device Technology

Questions to Ask Before Hiring Your QA/RA Consultant

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

Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry

The Future of Reprocessed Used Medical Equipment

Preventing the Death of Medical Device Sales

Lessons from an Industry Leader: Playing the Long Game of MedTech

Fraud in the Healthcare Industry & the Role of Whistleblowers

Demystifying the De Novo Process

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

What is Regulatory Due Diligence for Medical Devices?

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

What's New With PMAs

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

Latest Updates on CDRH Standards Program & IEC 60601

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

5 Actionable Lessons Learned from the RADx Initiative by NIH

Project Management for Product Development of Medical Devices

Prioritizing Medical Device Reimbursement During Product Development

7 Common 510(k) Mistakes and How to Avoid Them

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

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

Who Should Own Your QMS?

Navigating the Twists and Turns of Change Management for Medical Devices

Integrating Business Elements into Your Product Development Process with Therese Graff

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

The Intersection of Medical Device Usability and Risk Management

How to Build a QMS for a Medical Device

Meet a Guru: Sara Adams

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

Understanding The Differences Between Clearance vs Approval vs Granted

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Systematic Literature Review for EU MDR

Determining User Needs for Your Medical Device

Shaking Things Up: What's Next for the Global Medical Device Podcast

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Early Stage Territory Planning for Medical Device Companies

Meet a Guru: Maryann Mitchell

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Bringing Augmented Reality MedTech to Market

Why Integrating Business Elements into Your Medtech Development Process Is So Important

Tips for Success with IEC 60601 for Electrical Medical Devices

Implementing an eQMS after switching from Paper

Mastering the Pitch: MedTech Innovations from Concept to Market

Quality Myths & Lessons Learned Part II

The State of UDI Across the World

FDA's Voluntary Improvement Program

Project Management in MedTech

Is It Possible to "Buy" a QMS?

Speaking the Language of IVD

Managing Risk in Clinical Investigations

Bringing a Self-Funded Medical Device to Market

Building a Partnership with your Regulatory Consultant

Medical Device Reporting: The Do's and Don'ts

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