Greenlight Guru: Podcast

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The Danger of In-Home Use Medical Devices, Pt. 2

The Danger of In-Home Use Medical Devices, Pt. 2

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

The Trouble with Home-Use Devices, Pt. 1

Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

What Standards Apply to My Device?

Design of Experiments - How and When to Use DOE

MedTech Advice from an Accidental Entrepreneur

Navigating the Complex World of Combination Products

Meet the Guru: Building Quality Management in Early-Stage Medical Device Companies

Who Owns the Design Controls Process?

Designing a Medical Device for a Global User

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Clinical Evidence: The Key to Market Adoption

Creative Clinical Recruitment

Getting Hired In MedTech

Achieving ISO 13485 Certification

Meet a Guru: Jamie Bihary

Advice to Medical Device Inventors

Obtaining Institutional Review Board (IRB) Approval

Interviewing the Interviewer

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

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

Building a Partnership with your Regulatory Consultant

Bringing a Self-Funded Medical Device to Market

Managing Risk in Clinical Investigations

Speaking the Language of IVD

Is It Possible to "Buy" a QMS?

Project Management in MedTech

FDA's Voluntary Improvement Program

The State of UDI Across the World

Quality Myths & Lessons Learned Part II

Mastering the Pitch: MedTech Innovations from Concept to Market

Becoming a MedTech Regulatory Affairs Professional

How Artificial Intelligence is Impacting the MedTech Industry

Fundamentals of Quality & Regulatory

The State of AI & Clinical Investigations

The Evolving Landscape of AI in MedTech

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

Considerations for IVD

Human-Centered Design in Medical Devices

FDA's eSTAR Program

Using AI in MedTech

Becoming an Advisor to a Medical Device Company

Recent FDA Draft Guidances

Planning an FDA Submission

What NOT to say to FDA

Understanding LDTs & the FDA Proposed Ruling

UDI and EUDAMED: Past, Present and Future State

Selecting a Site for Your Clinical Trial

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

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

Accelerating SaMD Development in a Compliant Agile Way

MedTech Funding and Preparing for Due Diligence

Exploring Breakthrough Device Designation

Regulatory Strategy and the Advantage of Diversity in MedTech

28 Days To Save The World - True Quality Roadshow

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

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

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

The Role of dFMEA in Risk Management for Medical Devices

Understanding the ROI of an eQMS

CSA vs. CSV: Modern Validation for Modern MedTech

Management Responsibility: The most important part of a QMS

The Combination Products Handbook

Leaning into Lean Documentation

Cybersecurity and the Future of MedTech

Ad Promo and The Difference in Regulatory & Legal

How AI Can Help You Manage Risk

The Tools that Make Clinical Investigations

Complaint Handling with Medical Device Guru, Brittney McIver

Avoiding Potential Issues with your 510(k) Submission

Meet a Guru: Brittani Smith

Why Building Supplier Relationships Is So Important

Systematic Literature Review for EU MDR

Building Your Design Controls (and Pitfalls to Avoid)

Most Common Problems Found During FDA Inspections in 2022

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

Understanding the 'Compliance Manager' Role

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

How Communication Affects the Outcomes of Quality Activities

Part 2: The Theranos Loophole & Lab Developed Tests

Part 1: The Theranos Loophole & Lab Developed Tests

Implementing an eQMS after Switching from Paper

Essentials of Sterilization for Med Device Professionals

UDI: 101

Quality Myths and Lessons Learned

Determining User Needs for Your Medical Device

Fraud in the Healthcare Industry & the Role of Whistleblowers

Auditing the Auditor

What is MedTech Lifecycle Excellence?

The Best of Jon & Mike Through the Years

CDRH Proposed Guidance for FY 2023

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

The Future of Healthcare & How We Get There

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

Developing a Regulatory Strategy

We Achieved ISO Certification! Now what?

The Future of Reprocessed Used Medical Equipment

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

Customer Discovery for Medical Device Companies

EUA and the Impending Transition

Common QMS Mistakes SaMD Companies Make

Design Assurance: The Unsung Heroes of R&D

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

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

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

Best Practices for Clinical Evidence Management

Building Your Regulatory Strategy for Commercialization

Packaging Validation Best Practices

Overcoming Submission Deficiencies due to Biocompatibility

Does Your CAPA Process Need a CAPA?

UDI and the Current State of Global Implementation

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

Digitizing your SaMD Testing

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

Guerilla Tactics for Quality Leadership

Preventing the Death of Medical Device Sales

Shifting Sands of SaMD Cybersecurity Regulations

Early Stage Territory Planning for Medical Device Companies

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

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

Early Feasibility Studies in Latin America

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

Approaching Cybersecurity & Usability as a SaMD Company

The Future of Lateral Flow Test Technology

Building a Culture of Quality

Bringing Medical Devices Into The Home

Demystifying the De Novo Process

Challenges for Regulatory Submission: EU vs. US

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

The Future of Cybersecurity

Achieving Operational Readiness through Good Project Management

Bridging the Gap between Medical Devices and Clinical Data

MDSAP Approach - Navigating the Medical Device Single Audit Program

Bringing Augmented Reality MedTech to Market

Making Your Informational Meetings with FDA Valuable & Worthwhile

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

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

How Medical Device Intellectual Property Protection Varies by Sector

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

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

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

How to Select a Contract Manufacturer

A Regulatory Gap Analysis of FDA's Systems & Policies

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

Understanding the UDI System for Medical Devices

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

How Augmented Reality (AR) is Revolutionizing Healthcare

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

Why Usability Matters

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

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Setting the Record Straight on Usability & Human Factors

Project Management for Product Development of Medical Devices

Assessing the Global Regulatory Landscape

When to Throw the Least Burdensome Flag on FDA

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

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

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

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis

Understanding FDA's New Intended Use Rule and its Implications

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Tips for Running Better Management Reviews

Meet a Guru: Ryan Behringer

Navigating the MedTech Cybersecurity Ecosystem

Managing Clinical Data Activities

Explaining the Role of Importer under EU MDR

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

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

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

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

How Mindset Training Can Help Your Team Operate at Peak Performance

Examining the HHS Proposal for Premarket Notification Exemptions

Building your Brand as a Medical Device Professional

Understanding the Value of a Medical Device Guru

Meet a Guru: Etienne Nichols

Meet a Guru: Laura Court

Regulatory Tips & Pointers from a Former FDA Reviewer

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

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

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

Managing Business Risk as a Medical Device Company

Waterfall vs. Agile: Battle of the Product Development Methodologies

For the Love of Internal Auditing

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

Knowing vs. Doing as Medical Device Professionals

Pivoting Operations to Meet PPE Demand during Pandemic

Pros & Cons of Being a Physician turned MedTech Inventor

3 Systems of Risk for Medical Devices from FDA

Quality Management for IVD Devices vs Medical Devices

Understanding the Investigational Device Exemption (IDE) Process

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

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

Meet a Guru: Sara Adams

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

Building a Startup in the MedTech Industry

Meet a Guru: Karen Schuyler

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

Everything you Need to Know about SaMD from an FDA Perspective

Preparing for Remote and On-Site Inspections and Audits

How does EU MDR impact your Quality Management System?

Virtual Auditing in a Post-COVID World of Digital Compliance

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

Prioritizing Medical Device Reimbursement During Product Development

5 Actionable Lessons Learned from the RADx Initiative by NIH

What are the Strategic Priorities for CDRH in 2021?

Understanding and Handling Different Types of Feedback

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

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

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

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

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

What Goes into Designing Devices for Military and Emergency Applications?

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

Positive and Negative Impacts of EUA on the Medical Device Industry

Why Biocompatibility Should be Addressed by Every Medical Device Company

Meet a Guru: Erica Loring

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?

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

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

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

Tips for Success with IEC 60601 for Electrical Medical Devices

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?

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

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

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Why Design Verification Matters in Medical Device Design and Development

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

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

When Should You Start a QMS?

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

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

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

Importance of Software Requirements in Product Development

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

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

Creating a Culture of Quality for Medical Device Companies

Enabling MedTech Innovation through Cross-functionality

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

Improving the Colon Cancer Screening Experience

EU MDR: Not All Doom and Gloom

Biocompatibility Nuances and its Impact on Medical Devices

Advancing MRI Technology As We Know It Today

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

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

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

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

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

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

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

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 You Need To Know

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 QA/RA 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 IEC 60601

FDA Proposes Allowing 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

CAPA Process Mistakes You Want to Avoid

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 FDA 510(k) Submission

Understanding How to Use Real-World 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 (And How to Use It to Your Advantage)

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

How Process Excellence Leads to Product Excellence

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 Plus a Lean Approach 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 Developing a Treatment for Dysphagia with Rebecca Sheridan

Using the Bucket Method for Medical Device Risk Management

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

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

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

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

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

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, 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 Reed Tech’s Gary Saner

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

Tips to Help You Prepare for an FDA Inspection

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

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

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, a Member of the Standard's Working Group

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

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

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

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

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

Risk Management from a Regulatory & Product Development Perspective [Podcast]

How To Improve Your Design Reviews (Bonus Episode)

How To Improve Your Medical Device Design Reviews

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

Best Practices for Implementing Design Controls for the Medical Device Industry

The Danger of In-Home Use Medical Devices, Pt. 2

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