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Episodes

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

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

21:55 | 10.13.2021

When to Throw the Least Burdensome Flag on FDA

When to Throw the Least Burdensome Flag on FDA

34:52 | 10.06.2021

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

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

27:24 | 09.22.2021

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

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

38:04 | 09.15.2021

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

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

28:24 | 09.08.2021

Meet a Guru: Maryann Mitchell

Meet a Guru: Maryann Mitchell

15:49 | 09.01.2021

Why Storytelling Matters for Medical Device Companies

Why Storytelling Matters for Medical Device Companies

26:28 | 08.25.2021

A Breakthrough Device that Aims to Prevent Osteoporosis

A Breakthrough Device that Aims to Prevent Osteoporosis

24:35 | 08.18.2021

Understanding FDA's New Intended Use Rule and its Implications

Understanding FDA's New Intended Use Rule and its Implications

35:24 | 08.11.2021

eQMS in Academia: Practical Learning for Biomedical Engineering Students

eQMS in Academia: Practical Learning for Biomedical Engineering Students

36:00 | 07.28.2021

Tips for Running Better Management Reviews

Tips for Running Better Management Reviews

24:34 | 07.19.2021

Meet a Guru: Ryan Behringer

Meet a Guru: Ryan Behringer

27:51 | 07.14.2021

Navigating the MedTech Cybersecurity Ecosystem

Navigating the MedTech Cybersecurity Ecosystem

31:08 | 07.12.2021

Managing Clinical Data Activities

Managing Clinical Data Activities

24:01 | 07.07.2021

Explaining the Role of Importer under EU MDR

Explaining the Role of Importer under EU MDR

34:35 | 06.30.2021

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

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

36:29 | 06.23.2021

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

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

27:22 | 06.21.2021

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

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

15:14 | 06.16.2021

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

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

34:25 | 06.14.2021

How Mindset Training Can Help Your Team Operate at Peak Performance

How Mindset Training Can Help Your Team Operate at Peak Performance

28:30 | 06.09.2021

Examining the HHS Proposal for Premarket Notification Exemptions

Examining the HHS Proposal for Premarket Notification Exemptions

37:06 | 06.07.2021

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

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

31:35 | 06.02.2021

Building your Brand as a Medical Device Professional

37:15 | 05.31.2021

Understanding the Value of a Medical Device Guru

Understanding the Value of a Medical Device Guru

32:02 | 05.26.2021

Meet a Guru: Etienne Nichols

Meet a Guru: Etienne Nichols

30:22 | 05.24.2021

Meet a Guru: Laura Court

Meet a Guru: Laura Court

28:25 | 05.19.2021

Regulatory Tips & Pointers from a Former FDA Reviewer

Regulatory Tips & Pointers from a Former FDA Reviewer

47:41 | 05.17.2021

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

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

31:54 | 05.12.2021

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

41:02 | 05.11.2021

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

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

38:03 | 05.06.2021

Managing Business Risk as a Medical Device Company

Managing Business Risk as a Medical Device Company

34:25 | 05.03.2021

Waterfall vs. Agile: Battle of the Product Development Methodologies

Waterfall vs. Agile: Battle of the Product Development Methodologies

38:29 | 04.28.2021

For the Love of Internal Auditing

For the Love of Internal Auditing

33:27 | 04.26.2021

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

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

34:09 | 04.21.2021

Knowing vs. Doing as Medical Device Professionals

Knowing vs. Doing as Medical Device Professionals

31:46 | 04.19.2021

Pivoting Operations to Meet PPE Demand during Pandemic

Pivoting Operations to Meet PPE Demand during Pandemic

27:31 | 04.14.2021

Pros & Cons of Being a Physician turned MedTech Inventor

Pros & Cons of Being a Physician turned MedTech Inventor

49:07 | 04.13.2021

3 Systems of Risk for Medical Devices from FDA

3 Systems of Risk for Medical Devices from FDA

39:47 | 04.07.2021

Quality Management for IVD Devices vs Medical Devices

Quality Management for IVD Devices vs Medical Devices

41:48 | 04.05.2021

Understanding the Investigational Device Exemption (IDE) Process

Understanding the Investigational Device Exemption (IDE) Process

57:01 | 03.31.2021

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

22:05 | 03.30.2021

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

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

37:14 | 03.24.2021

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

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

32:47 | 03.21.2021

Meet a Guru: Sara Adams

Meet a Guru: Sara Adams

20:22 | 03.17.2021

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

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

46:16 | 03.25.2021

Building a Startup in the MedTech Industry

Building a Startup in the MedTech Industry

29:59 | 03.10.2021

Meet a Guru: Karen Schuyler

Meet a Guru: Karen Schuyler

25:50 | 03.08.2021

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

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

43:18 | 03.03.2021

Everything you Need to Know about SaMD from an FDA Perspective

Everything you Need to Know about SaMD from an FDA Perspective

46:12 | 03.01.2021

Preparing for Remote and On-Site Inspections and Audits

Preparing for Remote and On-Site Inspections and Audits

50:34 | 02.24.2021

How does EU MDR impact your Quality Management System?

How does EU MDR impact your Quality Management System?

36:02 | 02.22.2021

Virtual Auditing in a Post-COVID World of Digital Compliance

Virtual Auditing in a Post-COVID World of Digital Compliance

30:40 | 02.17.2021

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

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

40:10 | 02.10.2021

Prioritizing Medical Device Reimbursement During Product Development

Prioritizing Medical Device Reimbursement During Product Development

40:48 | 02.03.2021

5 Actionable Lessons Learned from the RADx Initiative by NIH

5 Actionable Lessons Learned from the RADx Initiative by NIH

47:52 | 01.27.2021

What are the Strategic Priorities for CDRH in 2021?

What are the Strategic Priorities for CDRH in 2021?

46:47 | 01.20.2021

Understanding and Handling Different Types of Feedback

Understanding and Handling Different Types of Feedback

34:08 | 01.14.2021

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

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

44:08 | 01.06.2021

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

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

42:40 | 12.23.2020

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

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

31:17 | 12.16.2020

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

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

39:17 | 12.09.2020

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

31:25 | 12.02.2020

What Goes into Designing Devices for Military and Emergency Applications?

What Goes into Designing Devices for Military and Emergency Applications?

38:45 | 11.25.2020

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

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

35:28 | 11.18.2020

Positive and Negative Impacts of EUA on the Medical Device Industry

Positive and Negative Impacts of EUA on the Medical Device Industry

37:39 | 11.11.2020

Why Biocompatibility Should be Addressed by Every Medical Device Company

Why Biocompatibility Should be Addressed by Every Medical Device Company

48:36 | 11.04.2020

Meet a Guru: Erica Loring

Meet a Guru: Erica Loring

38:19 | 10.27.2020

What is a Multiple Function Device?

What is a Multiple Function Device?

41:05 | 09.30.2020

Challenges related to Home Use Devices

Challenges related to Home Use Devices

30:54 | 09.10.2020

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

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

45:02 | 09.02.2020

How Jon Speer Met His Most Frequent Guest: Mike Drues

How Jon Speer Met His Most Frequent Guest: Mike Drues

40:50 | 08.26.2020

Meet a Guru: Wade Schroeder

Meet a Guru: Wade Schroeder

26:06 | 08.19.2020

What are the Audit Etiquette Rules I Should be Following?

What are the Audit Etiquette Rules I Should be Following?

36:21 | 08.12.2020

Meet a Guru: Tom Rish

Meet a Guru: Tom Rish

29:27 | 08.05.2020

Addressing Clinical Trial Challenges & Concerns during COVID-19

Addressing Clinical Trial Challenges & Concerns during COVID-19

38:43 | 07.29.2020

Protecting the Intellectual Property of your Medical Device Technology

Protecting the Intellectual Property of your Medical Device Technology

39:23 | 07.22.2020

Meet a GURU: Jesseca Lyons

Meet a GURU: Jesseca Lyons

36:57 | 07.15.2020

How to Build a QMS for a Medical Device

How to Build a QMS for a Medical Device

44:16 | 07.08.2020

Meet a Guru: Taylor Brown

Meet a Guru: Taylor Brown

43:04 | 07.01.2020

What is Regulatory Due Diligence for Medical Devices?

What is Regulatory Due Diligence for Medical Devices?

41:16 | 06.24.2020

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

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

32:56 | 06.17.2020

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

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

38:56 | 06.10.2020

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

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

42:45 | 06.03.2020

How to Construct an Effective Regulatory Strategy

How to Construct an Effective Regulatory Strategy

40:59 | 05.27.2020

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

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

36:49 | 05.20.2020

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

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

45:12 | 05.13.2020

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

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

43:42 | 05.06.2020

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

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

32:45 | 04.29.2020

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

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

30:11 | 04.22.2020

How to Approach Verification and Validation for Cloud Software

How to Approach Verification and Validation for Cloud Software

39:18 | 04.15.2020

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

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

24:19 | 04.10.2020

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

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

45:06 | 04.08.2020

How to Integrate Usability into your Medical Device

How to Integrate Usability into your Medical Device

30:43 | 04.01.2020

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

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

40:43 | 03.26.2020

How to Leverage IEC 62304 to Improve SaMD Development Processes

How to Leverage IEC 62304 to Improve SaMD Development Processes

37:00 | 03.18.2020

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

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

38:23 | 03.12.2020

How to Choose the Right FDA Regulatory Pathway for your Device

How to Choose the Right FDA Regulatory Pathway for your Device

38:45 | 02.26.2020

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

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

36:53 | 02.19.2020

4 Parts to Interviewing Candidates for Medical Device Roles

4 Parts to Interviewing Candidates for Medical Device Roles

34:10 | 02.12.2020

5 Tips for Hiring Medical Device Advisors

5 Tips for Hiring Medical Device Advisors

30:02 | 02.05.2020

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

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

37:11 | 01.29.2020

Navigating the Twists and Turns of Change Management for Medical Devices

Navigating the Twists and Turns of Change Management for Medical Devices

49:07 | 12.28.2019

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

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

33:21 | 12.18.2019

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

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

43:20 | 12.11.2019

How to Solve the Medtech Value Equation with Quality Data

How to Solve the Medtech Value Equation with Quality Data

32:32 | 12.05.2019

Why Supplier Quality Management Is So Important For Medical Device Companies

Why Supplier Quality Management Is So Important For Medical Device Companies

39:05 | 11.27.2019

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

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

36:40 | 11.26.2019

Preparing for EU MDR

Preparing for EU MDR

30:41 | 11.26.2019

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

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

35:01 | 11.07.2019

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

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

33:43 | 11.07.2019

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

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

36:22 | 11.07.2019

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

39:24 | 11.07.2019

Why Design Verification Matters in Medical Device Design and Development

Why Design Verification Matters in Medical Device Design and Development

40:35 | 11.07.2019

Implementing Changes to SaMD under New EU MDR

Implementing Changes to SaMD under New EU MDR

37:21 | 11.07.2019

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

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

30:11 | 11.07.2019

Right-sizing your QMS

Right-sizing your QMS

38:22 | 11.07.2019

Challenges with Pediatric Medical Devices

Challenges with Pediatric Medical Devices

30:59 | 11.07.2019

When Should You Start a QMS?

When Should You Start a QMS?

30:44 | 11.07.2019

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

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

34:18 | 11.07.2019

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

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

41:24 | 11.07.2019

Importance of Software Requirements in Product Development

Importance of Software Requirements in Product Development

32:09 | 11.07.2019

4 Facts That May Surprise You About FDA

4 Facts That May Surprise You About FDA

29:48 | 11.07.2019

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

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

37:24 | 11.07.2019

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

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

39:01 | 11.07.2019

Challenges with MedTech Innovation

Challenges with MedTech Innovation

34:11 | 11.07.2019

Is Your Medical Device Company CAPA Happy?

Is Your Medical Device Company CAPA Happy?

34:56 | 11.07.2019

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Integrating Human Factors into Design Controls to Improve Patient Outcomes

41:47 | 11.07.2019

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

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

35:35 | 11.07.2019

EU MDR: Not All Doom and Gloom

EU MDR: Not All Doom and Gloom

32:06 | 11.07.2019

Biocompatibility Nuances and its Impact on Medical Devices

Biocompatibility Nuances and its Impact on Medical Devices

37:59 | 11.07.2019

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

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

37:54 | 11.07.2019

The 100th Episode: A Few of My Favorite Moments

The 100th Episode: A Few of My Favorite Moments

12:24 | 11.07.2019

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

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

36:46 | 11.07.2019

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

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

38:06 | 11.07.2019

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

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

38:33 | 11.07.2019

Nonbinding Feedback is a New Guidance You Should Know About

Nonbinding Feedback is a New Guidance You Should Know About

37:31 | 11.07.2019

How and When to Consider Human Factors

How and When to Consider Human Factors

33:46 | 11.07.2019

Who Should Own Your QMS?

Who Should Own Your QMS?

23:44 | 11.07.2019

Design Validation vs. Human Factors Validation

Design Validation vs. Human Factors Validation

34:19 | 11.07.2019

Medical Device Product Development Value Proposition

Medical Device Product Development Value Proposition

32:33 | 11.07.2019

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

37:02 | 11.07.2019

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

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

32:16 | 11.07.2019

Aligning True Quality and Compliance with MDDAP

Aligning True Quality and Compliance with MDDAP

37:37 | 11.07.2019

Explaining the Significance of Voluntary Consensus Standards

Explaining the Significance of Voluntary Consensus Standards

30:05 | 11.07.2019

Medical Device Industry Predictions for 2019

Medical Device Industry Predictions for 2019

15:30 | 11.07.2019

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

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

31:59 | 11.07.2019

Understanding the Blurred Lines Between Consumer Tech and MedTech

Understanding the Blurred Lines Between Consumer Tech and MedTech

33:57 | 11.07.2019

Understanding The Differences Between Clearance vs Approval vs Granted

Understanding The Differences Between Clearance vs Approval vs Granted

31:52 | 11.07.2019

Streamlining The Device Marketing Authorization Process

Streamlining The Device Marketing Authorization Process

38:02 | 11.07.2019

The New Special 510(k)

The New Special 510(k)

44:39 | 11.07.2019

What's New With PMAs

What's New With PMAs

43:45 | 11.07.2019

How to Efficiently Raise Funds for Your Medical Device Company

How to Efficiently Raise Funds for Your Medical Device Company

34:35 | 11.07.2019

7 Habits of Highly Effective True Quality Medical Device Professionals

7 Habits of Highly Effective True Quality Medical Device Professionals

43:36 | 11.07.2019

Regulatory Tips & Observations from a Former FDA Reviewer

Regulatory Tips & Observations from a Former FDA Reviewer

31:59 | 11.07.2019

Questions to Ask Before Hiring Your QA/RA Consultant

Questions to Ask Before Hiring Your QA/RA Consultant

43:38 | 11.07.2019

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

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

31:13 | 11.07.2019

Latest Updates on CDRH Standards Program & IEC 60601

Latest Updates on CDRH Standards Program & IEC 60601

45:12 | 11.07.2019

15 Habits of Highly Effective Regulatory Professionals

15 Habits of Highly Effective Regulatory Professionals

42:45 | 11.07.2019

How to Embrace Risk for Safer Devices

How to Embrace Risk for Safer Devices

35:54 | 11.07.2019

What you Need to Know about FDA's Progressive Programs

What you Need to Know about FDA's Progressive Programs

35:53 | 11.07.2019

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

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

34:27 | 11.07.2019

The Bleeding Edge: Lessons Learned for the Medical Device Industry

The Bleeding Edge: Lessons Learned for the Medical Device Industry

45:48 | 11.07.2019

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

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

32:21 | 11.07.2019

How Human Factors Impact Your Medical Device

How Human Factors Impact Your Medical Device

42:56 | 11.07.2019

How to Think About Quality and Regulatory as Your Company Scales

How to Think About Quality and Regulatory as Your Company Scales

37:55 | 11.07.2019

How to Design for Compliance with IEC 60601

How to Design for Compliance with IEC 60601

33:58 | 11.07.2019

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

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

31:19 | 11.07.2019

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

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

43:03 | 11.07.2019

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

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

40:01 | 11.07.2019

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

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

27:45 | 11.07.2019

Helping Prepare Biomedical Engineers Entering the Workforce

Helping Prepare Biomedical Engineers Entering the Workforce

32:56 | 11.07.2019

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

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

35:17 | 11.07.2019

5 Most Common Problems With Your CAPA Process

5 Most Common Problems With Your CAPA Process

39:26 | 11.07.2019

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

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

25:07 | 11.07.2019

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

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

34:17 | 11.07.2019

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

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

29:01 | 11.07.2019

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

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

35:54 | 11.07.2019

Challenges with Applying Risk Management Throughout the Manufacturing Process

Challenges with Applying Risk Management Throughout the Manufacturing Process

21:09 | 11.07.2019

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

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

37:18 | 11.07.2019

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

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

35:45 | 11.07.2019

Lessons to Be Learned From Recent FDA Inspections

Lessons to Be Learned From Recent FDA Inspections

36:28 | 11.07.2019

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

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

30:35 | 11.07.2019

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

29:06 | 11.07.2019

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

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

32:25 | 11.07.2019

How Process Excellence Leads to Product Excellence

How Process Excellence Leads to Product Excellence

30:56 | 11.07.2019

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Understanding FDA’s Proposed Conformity Assessment Pilot Program

32:18 | 11.07.2019

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

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

31:23 | 11.07.2019

Understanding the Connection Between Complaints, CAPAs, and MDRs

Understanding the Connection Between Complaints, CAPAs, and MDRs

37:04 | 11.07.2019

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

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

28:05 | 11.07.2019

The Intersection of Medical Device Usability and Risk Management

The Intersection of Medical Device Usability and Risk Management

31:15 | 11.07.2019

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

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

30:56 | 11.07.2019

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

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

20:43 | 11.07.2019

An Overview of What Device Makers Need to Know About CAPA

An Overview of What Device Makers Need to Know About CAPA

37:45 | 11.07.2019

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

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

30:00 | 11.07.2019

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

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

34:12 | 11.07.2019

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

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

31:54 | 11.07.2019

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

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

31:49 | 11.07.2019

2016 Medical Device Regulatory Trends Year in Review

2016 Medical Device Regulatory Trends Year in Review

34:02 | 11.07.2019

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

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

33:57 | 11.07.2019

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

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

39:10 | 11.07.2019

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

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

21:56 | 11.07.2019

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

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

35:48 | 11.07.2019

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

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

32:57 | 11.07.2019

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

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

26:43 | 11.07.2019

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

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

32:11 | 11.07.2019

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

20:53 | 11.07.2019

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

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

30:34 | 11.07.2019

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

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

29:58 | 11.07.2019

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

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

31:45 | 11.07.2019

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

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

22:42 | 11.07.2019

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

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

27:33 | 11.07.2019

Tips to Help You Prepare for an FDA Inspection

Tips to Help You Prepare for an FDA Inspection

29:50 | 11.07.2019

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

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

31:21 | 11.07.2019

Integrating Business Elements into Your Product Development Process with Therese Graff

Integrating Business Elements into Your Product Development Process with Therese Graff

29:39 | 11.07.2019

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

27:10 | 11.07.2019

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

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

20:33 | 11.07.2019

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

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

27:16 | 11.07.2019

Medical Device Product Development Project Management Best Practices with Peter Sebelius

Medical Device Product Development Project Management Best Practices with Peter Sebelius

23:23 | 11.07.2019

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

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

27:30 | 11.07.2019

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

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

28:27 | 11.07.2019

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

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

26:14 | 11.07.2019

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

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

24:45 | 11.07.2019

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

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

25:42 | 11.07.2019

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

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

25:33 | 11.07.2019

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

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

30:10 | 11.07.2019

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

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

22:49 | 11.07.2019

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

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

21:24 | 11.07.2019

Risk Management from a Regulatory & Product Development Point of View

Risk Management from a Regulatory & Product Development Point of View

22:56 | 11.07.2019

How To Improve Your Medical Device Design Reviews

How To Improve Your Medical Device Design Reviews

24:04 | 11.07.2019

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

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

25:09 | 11.07.2019

Best Practices for Implementing Design Controls for the Medical Device Industry

Best Practices for Implementing Design Controls for the Medical Device Industry

26:35 | 11.07.2019

How to Improve Your Medical Device Design Reviews Bonus Episode

How to Improve Your Medical Device Design Reviews Bonus Episode

17:45 | 11.07.2019

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