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Global Medical Device Podcast powered by Greenlight Guru

Global Medical Device Podcast by Greenlight Guru is the witty health guru you never knew you needed. Steered by a team of experts with humor as sharp as a scalpel, this podcast dissects complex regulatory jargon with the precision of a seasoned surgeon. Our hosts, Jon Speer and Mike Drues, are the docs on call, breathing life into medical device bureaucracy. Their audience? Medical device geniuses looking to navigate the labyrinth of global regulations. With humour, wit and a prescription for practical advice, they tackle topics like FDA compliance and regulatory strategy. One must-catch episode is “An Overview of EU's MDR 2020 Regulations”. Surprise, humans can make regulations funny! There's more where that came from if you tune in and scrub up with the professionals at the Global Medical Device Podcast.

Latest Global Medical Device Podcast powered by Greenlight Guru Episodes

Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

Thu, 19 Dec 2024 05:30:00 -0500

Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

Thu, 12 Dec 2024 05:30:00 -0500

#395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

Fri, 06 Dec 2024 05:30:00 -0500

#394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

Fri, 29 Nov 2024 05:30:00 -0500

#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

Fri, 22 Nov 2024 05:30:00 -0500

#392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

Thu, 14 Nov 2024 05:30:00 -0500

#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

Thu, 07 Nov 2024 05:30:00 -0500

#390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

#389: Pre-determined Change Control Plans

Thu, 31 Oct 2024 05:30:00 -0500

#389: Pre-determined Change Control Plans

#388: Elements of an Effective CAPA Program

Thu, 24 Oct 2024 05:30:00 -0500

#388: Elements of an Effective CAPA Program

#387: The case for Real World Evidence Studies

Thu, 17 Oct 2024 05:30:00 -0500

#387: The case for Real World Evidence Studies

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

Thu, 10 Oct 2024 05:30:00 -0500

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

#385: The Trouble with Home-Use Devices, Pt. 1

Fri, 04 Oct 2024 05:30:00 -0500

#385: The Trouble with Home-Use Devices, Pt. 1

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

Thu, 26 Sep 2024 05:30:00 -0500

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

#383: What Standards Apply to My Device?

Thu, 19 Sep 2024 05:30:00 -0500

#383: What Standards Apply to My Device?

#382: Design of Experiments - How and When to Use DOE

Thu, 12 Sep 2024 05:30:00 -0500

#382: Design of Experiments - How and When to Use DOE

#381: MedTech Advice from an Accidental Entrepreneur

Thu, 05 Sep 2024 05:30:00 -0500

#381: MedTech Advice from an Accidental Entrepreneur

#380: Navigating the Complex World of Combination Products with Subhi Saadeh

Fri, 30 Aug 2024 05:30:00 -0500

#380: Navigating the Complex World of Combination Products with Subhi Saadeh

#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

Thu, 15 Aug 2024 05:30:00 -0500

#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

#378: Who Owns the Design Controls Process?

Thu, 08 Aug 2024 05:30:00 -0500

#378: Who Owns the Design Controls Process?

#377: Designing a Medical Device for a Global User

Thu, 25 Jul 2024 05:00:00 -0500

#377: Designing a Medical Device for a Global User

#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

Thu, 18 Jul 2024 06:00:00 -0500

#376: FDA's Proposed Wound Dressing Rule: Industry Impacts and Regulatory Insights

#375: Direct to Consumer - The Future of Healthcare

Thu, 11 Jul 2024 06:00:00 -0500

#375: Direct to Consumer - The Future of Healthcare

#374: Clinical Evidence - The Key to Market Adoption

Tue, 25 Jun 2024 05:30:00 -0500

#374: Clinical Evidence - The Key to Market Adoption

#373: Creative Clinical Recruitment

Thu, 06 Jun 2024 05:30:00 -0500

#373: Creative Clinical Recruitment

#372: Getting Hired In MedTech

Tue, 04 Jun 2024 05:00:00 -0500

#372: Getting Hired In MedTech

#370: Meet a Guru: Jamie Bihary

Thu, 30 May 2024 05:00:00 -0500

#370: Meet a Guru: Jamie Bihary

#371: Achieving ISO 13485 Certification

Tue, 28 May 2024 05:00:00 -0500

#371: Achieving ISO 13485 Certification

#369: Advice to Medical Device Inventors

Thu, 23 May 2024 05:00:00 -0500

#369: Advice to Medical Device Inventors

#368: Institutional Review Boards (IRBs)

Tue, 21 May 2024 05:00:00 -0500

#368: Institutional Review Boards (IRBs)

#367: Interviewing the Interviewer

Thu, 16 May 2024 00:00:00 -0500

#367: Interviewing the Interviewer

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

Thu, 09 May 2024 05:00:00 -0500

#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

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

Tue, 07 May 2024 05:00:00 -0500

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

#363: Bringing a Self-Funded Medical Device to Market

Thu, 02 May 2024 05:00:00 -0500

#363: Bringing a Self-Funded Medical Device to Market

#364: Building a Partnership with your Regulatory Consultant

Tue, 30 Apr 2024 05:00:00 -0500

#364: Building a Partnership with your Regulatory Consultant

#362: Managing Risk in Clinical Investigations

Thu, 25 Apr 2024 05:00:00 -0500

#362: Managing Risk in Clinical Investigations

#361: Speaking the Language of IVD

Thu, 18 Apr 2024 20:20:00 -0500

#361: Speaking the Language of IVD

#360: Is It Possible to "Buy" a QMS?

Thu, 11 Apr 2024 05:30:00 -0500

#360: Is It Possible to "Buy" a QMS?

#359: Project Management in MedTech

Thu, 04 Apr 2024 05:30:00 -0500

#359: Project Management in MedTech

#358: FDAs Voluntary Improvement Program

Thu, 21 Mar 2024 05:30:00 -0500

#358: FDAs Voluntary Improvement Program

#357: The State of UDI Across the World

Thu, 07 Mar 2024 06:00:00 -0500

#357: The State of UDI Across the World

#356: Quality Myths & Lessons Learned Part II

Thu, 22 Feb 2024 06:00:00 -0500

#356: Quality Myths & Lessons Learned Part II

#355: Mastering the Pitch: MedTech Innovations from Concept to Market

Thu, 15 Feb 2024 05:00:00 -0500

#355: Mastering the Pitch: MedTech Innovations from Concept to Market

#354: Advice for MedTech Regulatory Affairs Professionals

Wed, 07 Feb 2024 05:00:00 -0500

#354: Advice for MedTech Regulatory Affairs Professionals

#353: How Artificial Intelligence is Impacting the MedTech Industry

Tue, 30 Jan 2024 06:00:00 -0500

#353: How Artificial Intelligence is Impacting the MedTech Industry

#352: Fundamentals of Quality & Regulatory

Thu, 18 Jan 2024 06:00:00 -0500

#352: Fundamentals of Quality & Regulatory

#351: The State of AI & Clinical Investigations

Thu, 11 Jan 2024 06:00:00 -0500

#351: The State of AI & Clinical Investigations

#350: The Evolving Landscape of AI in MedTech

Thu, 04 Jan 2024 06:00:00 -0500

#350: The Evolving Landscape of AI in MedTech

#349: Climbing the MedTech Career Ladder - How to Get to the Top

Thu, 21 Dec 2023 06:00:00 -0500

#349: Climbing the MedTech Career Ladder - How to Get to the Top

#348: Considerations for IVD

Thu, 14 Dec 2023 07:00:00 -0500

#348: Considerations for IVD

#347: Human-Centered Design in Medical Devices

Thu, 07 Dec 2023 07:00:00 -0500

#347: Human-Centered Design in Medical Devices

#346: FDAs eSTAR Program

Thu, 30 Nov 2023 07:00:00 -0500

#346: FDAs eSTAR Program

#345: Using AI In MedTech

Wed, 22 Nov 2023 06:00:00 -0500

#345: Using AI In MedTech

#344: Becoming an Advisor to a Medical Device Company

Thu, 16 Nov 2023 07:00:00 -0500

#344: Becoming an Advisor to a Medical Device Company

#343: Recent FDA Draft Guidances

Thu, 09 Nov 2023 07:30:00 -0500

#343: Recent FDA Draft Guidances

#342: Planning an FDA Submission

Thu, 02 Nov 2023 16:30:00 -0500

#342: Planning an FDA Submission

#341: What NOT to say to FDA

Wed, 25 Oct 2023 07:00:00 -0500

#341: What NOT to say to FDA

#340: LDTs & the FDAs Proposed Ruling

Thu, 19 Oct 2023 19:34:00 -0500

#340: LDTs & the FDAs Proposed Ruling

#339: UDI and the State of EUDAMED

Thu, 12 Oct 2023 06:00:00 -0500

#339: UDI and the State of EUDAMED

#338: Site Selection for Clinical Trials

Thu, 05 Oct 2023 23:00:00 -0500

#338: Site Selection for Clinical Trials

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

Thu, 21 Sep 2023 06:00:00 -0500

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

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

Thu, 14 Sep 2023 15:30:00 -0500

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

#335: Accelerating SaMD Development in a Compliant Agile way

Fri, 08 Sep 2023 12:30:00 -0500

#335: Accelerating SaMD Development in a Compliant Agile way

#334: MedTech Funding and Preparing for Due Diligence

Thu, 31 Aug 2023 07:00:00 -0500

#334: MedTech Funding and Preparing for Due Diligence

#333: Exploring Breakthrough Device Designation

Thu, 24 Aug 2023 21:05:00 -0500

#333: Exploring Breakthrough Device Designation

#332: Regulatory Strategy and the Advantage of Diversity in MedTech

Thu, 17 Aug 2023 07:00:00 -0500

#332: Regulatory Strategy and the Advantage of Diversity in MedTech

#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues

Wed, 09 Aug 2023 21:00:00 -0500

#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

Thu, 03 Aug 2023 08:00:00 -0500

#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

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

Wed, 26 Jul 2023 21:06:00 -0500

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

#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Thu, 20 Jul 2023 14:36:00 -0500

#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

#327 Understanding the ROI of an eQMS

Tue, 11 Jul 2023 03:25:00 -0500

#327 Understanding the ROI of an eQMS

#326 CSA vs. CSV: Modern Validation for Modern MedTech

Fri, 07 Jul 2023 09:00:00 -0500

#326 CSA vs. CSV: Modern Validation for Modern MedTech

#325 The Role of dFMEAs in Risk Management for Medical Devices

Thu, 29 Jun 2023 20:28:00 -0500

#325 The Role of dFMEAs in Risk Management for Medical Devices

#324 Management Responsibility: The most important part of a QMS

Thu, 22 Jun 2023 19:11:00 -0500

#324 Management Responsibility: The most important part of a QMS

#323 The Combination Products Handbook

Thu, 15 Jun 2023 23:05:00 -0500

#323 The Combination Products Handbook

Leaning into Lean Documentation

Wed, 07 Jun 2023 17:32:23 -0500

Leaning into Lean Documentation

Cybersecurity and the Future of MedTech

Fri, 02 Jun 2023 14:23:28 -0500

Cybersecurity and the Future of MedTech

How AI Can Help You Manage Risk

Fri, 26 May 2023 17:39:08 -0500

How AI Can Help You Manage Risk

Ad Promo and The Difference in Regulatory & Legal

Wed, 24 May 2023 16:55:00 -0500

Ad Promo and The Difference in Regulatory & Legal

The Tools that Make Clinical Investigations

Fri, 12 May 2023 20:40:00 -0500

The Tools that Make Clinical Investigations

Complaint Handling with Medical Device Guru, Brittney McIver

Wed, 03 May 2023 16:34:24 -0500

Complaint Handling with Medical Device Guru, Brittney McIver

Avoiding Potential Issues with your 510(k) Submission

Thu, 27 Apr 2023 19:33:56 -0500

Avoiding Potential Issues with your 510(k) Submission

Meet a Guru: Brittani Smith

Thu, 20 Apr 2023 18:41:51 -0500

Meet a Guru: Brittani Smith

Why Building Supplier Relationships Is So Important

Wed, 12 Apr 2023 18:43:17 -0500

Why Building Supplier Relationships Is So Important

Systematic Literature Review for EU MDR

Wed, 05 Apr 2023 17:22:59 -0500

Systematic Literature Review for EU MDR

Building Your Design Controls (and Pitfalls to Avoid)

Wed, 29 Mar 2023 16:09:31 -0500

Building Your Design Controls (and Pitfalls to Avoid)

Most Common Problems Found During FDA Inspections in 2022

Thu, 23 Mar 2023 19:17:13 -0500

Most Common Problems Found During FDA Inspections in 2022

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

Wed, 15 Mar 2023 19:27:17 -0500

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

Understanding the 'Compliance Manager' Role

Wed, 08 Mar 2023 21:32:22 -0500

Understanding the 'Compliance Manager' Role

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

Wed, 01 Mar 2023 22:41:57 -0500

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

How Communication Affects the Outcomes of Quality Activities

Wed, 22 Feb 2023 21:13:31 -0500

How Communication Affects the Outcomes of Quality Activities

Part 2: The Theranos Loophole & Lab Developed Tests

Wed, 15 Feb 2023 20:48:45 -0500

Part 2: The Theranos Loophole & Lab Developed Tests

Part 1: The Theranos Loophole & Lab Developed Tests

Thu, 09 Feb 2023 20:01:00 -0500

Part 1: The Theranos Loophole & Lab Developed Tests

Implementing an eQMS after Switching from Paper

Wed, 01 Feb 2023 20:12:08 -0500

Implementing an eQMS after Switching from Paper

Essentials of Sterilization for Med Device Professionals

Wed, 25 Jan 2023 20:41:09 -0500

Essentials of Sterilization for Med Device Professionals

UDI: 101

Fri, 20 Jan 2023 20:55:07 -0500

UDI: 101

Quality Myths and Lessons Learned

Wed, 18 Jan 2023 21:16:04 -0500

Quality Myths and Lessons Learned

Determining User Needs for Your Medical Device

Fri, 13 Jan 2023 20:21:57 -0500

Determining User Needs for Your Medical Device

Fraud in the Healthcare Industry & the Role of Whistleblowers

Wed, 11 Jan 2023 20:20:17 -0500

Fraud in the Healthcare Industry & the Role of Whistleblowers

Auditing the Auditor

Fri, 06 Jan 2023 21:03:35 -0500

Auditing the Auditor

What is MedTech Lifecycle Excellence?

Thu, 05 Jan 2023 18:24:37 -0500

What is MedTech Lifecycle Excellence?

The Best of Jon & Mike Through the Years

Wed, 28 Dec 2022 21:39:02 -0500

The Best of Jon & Mike Through the Years

CDRH Proposed Guidance for FY 2023

Wed, 21 Dec 2022 21:34:02 -0500

CDRH Proposed Guidance for FY 2023

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

Wed, 14 Dec 2022 21:07:20 -0500

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

The Future of Healthcare & How We Get There

Wed, 07 Dec 2022 20:19:22 -0500

The Future of Healthcare & How We Get There

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

Wed, 30 Nov 2022 17:54:07 -0500

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

Developing a Regulatory Strategy

Wed, 23 Nov 2022 16:38:02 -0500

Developing a Regulatory Strategy

We Achieved ISO Certification! Now What?

Wed, 16 Nov 2022 20:36:09 -0500

We Achieved ISO Certification! Now What?

The Future of Reprocessed Used Medical Equipment

Thu, 10 Nov 2022 21:03:06 -0500

The Future of Reprocessed Used Medical Equipment

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

Fri, 04 Nov 2022 15:30:00 -0500

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

Customer Discovery for Medical Device Companies

Wed, 02 Nov 2022 04:00:00 -0500

Customer Discovery for Medical Device Companies

EUA and the Impending Transition

Wed, 26 Oct 2022 04:00:00 -0500

EUA and the Impending Transition

Common QMS Mistakes SaMD Companies Make

Thu, 20 Oct 2022 21:06:35 -0500

Common QMS Mistakes SaMD Companies Make

Design Assurance: The Unsung Heroes of R&D

Thu, 13 Oct 2022 15:42:09 -0500

Design Assurance: The Unsung Heroes of R&D

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

Thu, 06 Oct 2022 15:13:11 -0500

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

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

Thu, 29 Sep 2022 13:25:48 -0500

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

Best Practices for Clinical Evidence Management

Thu, 22 Sep 2022 18:06:19 -0500

Best Practices for Clinical Evidence Management

Building Your Regulatory Strategy for Commercialization

Wed, 14 Sep 2022 16:57:10 -0500

Building Your Regulatory Strategy for Commercialization

Packaging Validation Best Practices

Wed, 07 Sep 2022 19:19:29 -0500

Packaging Validation Best Practices

Overcoming Submission Deficiencies due to Biocompatibility

Wed, 31 Aug 2022 20:38:24 -0500

Overcoming Submission Deficiencies due to Biocompatibility

Does Your CAPA Process Need a CAPA?

Wed, 24 Aug 2022 15:37:24 -0500

Does Your CAPA Process Need a CAPA?

UDI and the Current State of Global Implementation

Wed, 17 Aug 2022 20:10:05 -0500

UDI and the Current State of Global Implementation

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

Wed, 10 Aug 2022 18:24:33 -0500

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

Digitizing your SaMD Testing

Wed, 03 Aug 2022 17:19:27 -0500

Digitizing your SaMD Testing

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

Wed, 27 Jul 2022 17:13:49 -0500

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

Guerilla Tactics for Quality Leadership

Wed, 20 Jul 2022 18:35:31 -0500

Guerilla Tactics for Quality Leadership

Preventing the Death of Medical Device Sales

Wed, 13 Jul 2022 18:52:10 -0500

Preventing the Death of Medical Device Sales

Shifting Sands of SaMD Cybersecurity Regulations

Tue, 05 Jul 2022 20:11:21 -0500

Shifting Sands of SaMD Cybersecurity Regulations

Early Stage Territory Planning for Medical Device Companies

Wed, 29 Jun 2022 18:29:31 -0500

Early Stage Territory Planning for Medical Device Companies

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

Wed, 22 Jun 2022 19:36:10 -0500

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

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

Thu, 16 Jun 2022 17:40:06 -0500

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

Early Feasibility Studies in Latin America

Wed, 08 Jun 2022 18:34:51 -0500

Early Feasibility Studies in Latin America

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

Wed, 01 Jun 2022 19:38:24 -0500

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

Approaching Cybersecurity & Usability as a SaMD Company

Fri, 27 May 2022 20:56:08 -0500

Approaching Cybersecurity & Usability as a SaMD Company

The Future of Lateral Flow Test Technology

Wed, 25 May 2022 17:14:41 -0500

The Future of Lateral Flow Test Technology

Building a Culture of Quality

Fri, 20 May 2022 18:11:26 -0500

Building a Culture of Quality

Bringing Medical Devices into the Home

Wed, 18 May 2022 19:17:57 -0500

Bringing Medical Devices into the Home

Demystifying the De Novo Process

Thu, 12 May 2022 18:37:46 -0500

Demystifying the De Novo Process

Challenges for Regulatory Submission: EU vs. US

Fri, 06 May 2022 17:37:48 -0500

Challenges for Regulatory Submission: EU vs. US

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Wed, 04 May 2022 14:37:54 -0500

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

The Future of Cybersecurity

Fri, 29 Apr 2022 20:35:34 -0500

The Future of Cybersecurity

Achieving Operational Readiness through Good Project Management

Wed, 27 Apr 2022 18:43:42 -0500

Achieving Operational Readiness through Good Project Management

Bridging the Gap between Medical Devices and Clinical Data

Wed, 20 Apr 2022 18:47:01 -0500

Bridging the Gap between Medical Devices and Clinical Data

Navigating the Medical Device Single Audit Program (MDSAP)

Wed, 13 Apr 2022 15:44:14 -0500

Navigating the Medical Device Single Audit Program (MDSAP)

Bringing Augmented Reality MedTech to Market

Wed, 06 Apr 2022 21:31:47 -0500

Bringing Augmented Reality MedTech to Market

Making Your Informational Meetings with FDA Valuable & Worthwhile

Wed, 30 Mar 2022 19:20:31 -0500

Making Your Informational Meetings with FDA Valuable & Worthwhile

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

Wed, 23 Mar 2022 17:24:37 -0500

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

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

Wed, 16 Mar 2022 15:50:07 -0500

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

How Medical Device Intellectual Property Protection Varies by Sector

Wed, 09 Mar 2022 19:36:03 -0500

How Medical Device Intellectual Property Protection Varies by Sector

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

Wed, 02 Mar 2022 18:35:53 -0500

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

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

Wed, 23 Feb 2022 17:47:58 -0500

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

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

Wed, 16 Feb 2022 20:38:07 -0500

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

How to Select a Contract Manufacturer

Wed, 02 Feb 2022 18:43:03 -0500

How to Select a Contract Manufacturer

A Regulatory Gap Analysis of FDA's Systems & Policies

Wed, 26 Jan 2022 19:41:59 -0500

A Regulatory Gap Analysis of FDA's Systems & Policies

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

Wed, 12 Jan 2022 19:13:59 -0500

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

Understanding the UDI System for Medical Devices

Wed, 05 Jan 2022 21:06:23 -0500

Understanding the UDI System for Medical Devices

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

Thu, 16 Dec 2021 15:17:24 -0500

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

How Augmented Reality (AR) is Revolutionizing Healthcare

Wed, 08 Dec 2021 22:02:01 -0500

How Augmented Reality (AR) is Revolutionizing Healthcare

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

Wed, 01 Dec 2021 21:31:39 -0500

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

Why Usability Matters

Wed, 24 Nov 2021 15:12:38 -0500

Why Usability Matters

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

Wed, 17 Nov 2021 19:10:59 -0500

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

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Wed, 10 Nov 2021 18:42:48 -0500

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Setting the Record Straight on Usability & Human Factors

Wed, 03 Nov 2021 14:45:05 -0500

Setting the Record Straight on Usability & Human Factors

Project Management for Product Development of Medical Devices

Wed, 27 Oct 2021 17:45:08 -0500

Project Management for Product Development of Medical Devices

Assessing the Global Regulatory Landscape

Wed, 20 Oct 2021 21:21:13 -0500

Assessing the Global Regulatory Landscape

When to Throw the Least Burdensome Flag on FDA

Wed, 06 Oct 2021 16:25:12 -0500

When to Throw the Least Burdensome Flag on FDA

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

Wed, 22 Sep 2021 18:20:37 -0500

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

Wed, 15 Sep 2021 20:22:55 -0500

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

Wed, 08 Sep 2021 19:40:07 -0500

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

Meet a Guru: Maryann Mitchell

Wed, 01 Sep 2021 20:42:21 -0500

Meet a Guru: Maryann Mitchell

Why Storytelling Matters for Medical Device Companies

Wed, 25 Aug 2021 19:19:14 -0500

Why Storytelling Matters for Medical Device Companies

A Breakthrough Device that Aims to Prevent Osteoporosis

Wed, 18 Aug 2021 21:50:37 -0500

A Breakthrough Device that Aims to Prevent Osteoporosis

Understanding FDA's New Intended Use Rule and its Implications

Wed, 11 Aug 2021 13:42:22 -0500

Understanding FDA's New Intended Use Rule and its Implications

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Wed, 28 Jul 2021 19:03:51 -0500

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Tips for Running Better Management Reviews

Mon, 19 Jul 2021 17:30:53 -0500

Tips for Running Better Management Reviews

Meet a Guru: Ryan Behringer

Wed, 14 Jul 2021 15:50:11 -0500

Meet a Guru: Ryan Behringer

Navigating the MedTech Cybersecurity Ecosystem

Mon, 12 Jul 2021 20:02:39 -0500

Navigating the MedTech Cybersecurity Ecosystem

Managing Clinical Data Activities

Wed, 07 Jul 2021 19:57:49 -0500

Managing Clinical Data Activities

Explaining the Role of Importer under EU MDR

Wed, 30 Jun 2021 20:37:20 -0500

Explaining the Role of Importer under EU MDR

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

Wed, 23 Jun 2021 16:38:06 -0500

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

Mon, 21 Jun 2021 15:07:23 -0500

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

Wed, 16 Jun 2021 17:02:10 -0500

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

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

Mon, 14 Jun 2021 17:29:06 -0500

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

How Mindset Training Can Help Your Team Operate at Peak Performance

Wed, 09 Jun 2021 19:33:56 -0500

How Mindset Training Can Help Your Team Operate at Peak Performance

Examining the HHS Proposal for Premarket Notification Exemptions

Mon, 07 Jun 2021 15:37:35 -0500

Examining the HHS Proposal for Premarket Notification Exemptions

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

Wed, 02 Jun 2021 18:47:36 -0500

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

Building your Brand as a Medical Device Professional

Mon, 31 May 2021 12:45:00 -0500

Building your Brand as a Medical Device Professional

Understanding the Value of a Medical Device Guru

Wed, 26 May 2021 18:21:30 -0500

Understanding the Value of a Medical Device Guru

Meet a Guru: Etienne Nichols

Mon, 24 May 2021 17:45:45 -0500

Meet a Guru: Etienne Nichols

Meet a Guru: Laura Court

Wed, 19 May 2021 16:55:38 -0500

Meet a Guru: Laura Court

Regulatory Tips & Pointers from a Former FDA Reviewer

Mon, 17 May 2021 15:14:10 -0500

Regulatory Tips & Pointers from a Former FDA Reviewer

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

Wed, 12 May 2021 18:52:31 -0500

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

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Tue, 11 May 2021 17:38:37 -0500

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

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

Thu, 06 May 2021 20:17:26 -0500

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

Managing Business Risk as a Medical Device Company

Mon, 03 May 2021 18:34:13 -0500

Managing Business Risk as a Medical Device Company

Waterfall vs. Agile: Battle of the Product Development Methodologies

Wed, 28 Apr 2021 16:51:28 -0500

Waterfall vs. Agile: Battle of the Product Development Methodologies

For the Love of Internal Auditing

Mon, 26 Apr 2021 19:50:55 -0500

For the Love of Internal Auditing

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

Wed, 21 Apr 2021 17:57:39 -0500

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

Knowing vs. Doing as Medical Device Professionals

Mon, 19 Apr 2021 19:51:06 -0500

Knowing vs. Doing as Medical Device Professionals

Pivoting Operations to Meet PPE Demand during Pandemic

Wed, 14 Apr 2021 12:50:48 -0500

Pivoting Operations to Meet PPE Demand during Pandemic

Pros & Cons of Being a Physician turned MedTech Inventor

Tue, 13 Apr 2021 13:13:31 -0500

Pros & Cons of Being a Physician turned MedTech Inventor

3 Systems of Risk for Medical Devices from FDA

Wed, 07 Apr 2021 19:50:52 -0500

3 Systems of Risk for Medical Devices from FDA

Quality Management for IVD Devices vs Medical Devices

Mon, 05 Apr 2021 16:07:49 -0500

Quality Management for IVD Devices vs Medical Devices

Understanding the Investigational Device Exemption (IDE) Process

Wed, 31 Mar 2021 15:13:50 -0500

Understanding the Investigational Device Exemption (IDE) Process

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Tue, 30 Mar 2021 13:51:14 -0500

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

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

Thu, 25 Mar 2021 14:03:42 -0500

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

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

Wed, 24 Mar 2021 14:08:00 -0500

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

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

Sun, 21 Mar 2021 17:00:00 -0500

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

Meet a Guru: Sara Adams

Wed, 17 Mar 2021 12:45:00 -0500

Meet a Guru: Sara Adams

Building a Startup in the MedTech Industry

Wed, 10 Mar 2021 16:25:10 -0500

Building a Startup in the MedTech Industry

Meet a Guru: Karen Schuyler

Mon, 08 Mar 2021 15:25:24 -0500

Meet a Guru: Karen Schuyler

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

Wed, 03 Mar 2021 21:37:43 -0500

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

Everything you Need to Know about SaMD from an FDA Perspective

Mon, 01 Mar 2021 15:41:54 -0500

Everything you Need to Know about SaMD from an FDA Perspective

Preparing for Remote and On-Site Inspections and Audits

Wed, 24 Feb 2021 18:23:12 -0500

Preparing for Remote and On-Site Inspections and Audits

How does EU MDR impact your Quality Management System?

Mon, 22 Feb 2021 15:41:00 -0500

How does EU MDR impact your Quality Management System?

Virtual Auditing in a Post-COVID World of Digital Compliance

Wed, 17 Feb 2021 21:32:26 -0500

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

Wed, 10 Feb 2021 18:52:08 -0500

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

Prioritizing Medical Device Reimbursement During Product Development

Wed, 03 Feb 2021 20:13:50 -0500

Prioritizing Medical Device Reimbursement During Product Development

5 Actionable Lessons Learned from the RADx Initiative by NIH

Wed, 27 Jan 2021 18:21:46 -0500

5 Actionable Lessons Learned from the RADx Initiative by NIH

What are the Strategic Priorities for CDRH in 2021?

Wed, 20 Jan 2021 15:26:06 -0500

What are the Strategic Priorities for CDRH in 2021?

Understanding and Handling Different Types of Feedback

Thu, 14 Jan 2021 14:44:12 -0500

Understanding and Handling Different Types of Feedback

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

Wed, 06 Jan 2021 21:20:51 -0500

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

Wed, 23 Dec 2020 17:59:50 -0500

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

Wed, 16 Dec 2020 21:42:15 -0500

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?

Wed, 09 Dec 2020 18:55:36 -0500

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

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Wed, 02 Dec 2020 16:58:40 -0500

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

What Goes into Designing Devices for Military and Emergency Applications?

Wed, 25 Nov 2020 20:27:10 -0500

What Goes into Designing Devices for Military and Emergency Applications?

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

Wed, 18 Nov 2020 19:55:54 -0500

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

Positive and Negative Impacts of EUA on the Medical Device Industry

Wed, 11 Nov 2020 20:07:22 -0500

Positive and Negative Impacts of EUA on the Medical Device Industry

Why Biocompatibility Should be Addressed by Every Medical Device Company

Wed, 04 Nov 2020 18:10:41 -0500

Why Biocompatibility Should be Addressed by Every Medical Device Company

Meet a Guru: Erica Loring

Tue, 27 Oct 2020 20:01:19 -0500

Meet a Guru: Erica Loring

What is a Multiple Function Device?

Wed, 30 Sep 2020 17:20:57 -0500

What is a Multiple Function Device?

Challenges related to Home Use Devices

Thu, 10 Sep 2020 14:45:34 -0500

Challenges related to Home Use Devices

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

Wed, 02 Sep 2020 17:23:48 -0500

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

How Jon Speer Met His Most Frequent Guest: Mike Drues

Wed, 26 Aug 2020 18:38:36 -0500

How Jon Speer Met His Most Frequent Guest: Mike Drues

Meet a Guru: Wade Schroeder

Wed, 19 Aug 2020 19:26:33 -0500

Meet a Guru: Wade Schroeder

What are the Audit Etiquette Rules I Should be Following?

Wed, 12 Aug 2020 16:21:33 -0500

What are the Audit Etiquette Rules I Should be Following?

Meet a Guru: Tom Rish

Wed, 05 Aug 2020 18:49:43 -0500

Meet a Guru: Tom Rish

Addressing Clinical Trial Challenges & Concerns during COVID-19

Wed, 29 Jul 2020 18:56:38 -0500

Addressing Clinical Trial Challenges & Concerns during COVID-19

Protecting the Intellectual Property of your Medical Device Technology

Wed, 22 Jul 2020 15:33:08 -0500

Protecting the Intellectual Property of your Medical Device Technology

Meet a GURU: Jesseca Lyons

Wed, 15 Jul 2020 16:15:26 -0500

Meet a GURU: Jesseca Lyons

How to Build a QMS for a Medical Device

Wed, 08 Jul 2020 17:04:31 -0500

How to Build a QMS for a Medical Device

Meet a Guru: Taylor Brown

Wed, 01 Jul 2020 16:37:01 -0500

Meet a Guru: Taylor Brown

What is Regulatory Due Diligence for Medical Devices?

Wed, 24 Jun 2020 18:49:31 -0500

What is Regulatory Due Diligence for Medical Devices?

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

Wed, 17 Jun 2020 19:34:35 -0500

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

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

Wed, 10 Jun 2020 20:03:22 -0500

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

Wed, 03 Jun 2020 16:26:59 -0500

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

How to Construct an Effective Regulatory Strategy

Wed, 27 May 2020 14:39:52 -0500

How to Construct an Effective Regulatory Strategy

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

Wed, 20 May 2020 19:26:39 -0500

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

Wed, 13 May 2020 16:23:13 -0500

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

Wed, 06 May 2020 16:12:28 -0500

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

Wed, 29 Apr 2020 14:00:48 -0500

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

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

Wed, 22 Apr 2020 18:44:09 -0500

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

How to Approach Verification and Validation for Cloud Software

Wed, 15 Apr 2020 17:28:01 -0500

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

Fri, 10 Apr 2020 17:57:30 -0500

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

Wed, 08 Apr 2020 13:22:03 -0500

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

How to Integrate Usability into your Medical Device

Wed, 01 Apr 2020 16:31:19 -0500

How to Integrate Usability into your Medical Device

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

Thu, 26 Mar 2020 13:00:20 -0500

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

How to Leverage IEC 62304 to Improve SaMD Development Processes

Wed, 18 Mar 2020 16:14:58 -0500

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?

Thu, 12 Mar 2020 14:57:39 -0500

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

Wed, 26 Feb 2020 14:13:40 -0500

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

Wed, 19 Feb 2020 14:49:16 -0500

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

4 Parts to Interviewing Candidates for Medical Device Roles

Wed, 12 Feb 2020 20:42:51 -0500

4 Parts to Interviewing Candidates for Medical Device Roles

5 Tips for Hiring Medical Device Advisors

Wed, 05 Feb 2020 15:47:16 -0500

5 Tips for Hiring Medical Device Advisors

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

Wed, 29 Jan 2020 16:41:38 -0500

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

Navigating the Twists and Turns of Change Management for Medical Devices

Sat, 28 Dec 2019 15:55:48 -0500

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?

Wed, 18 Dec 2019 20:39:19 -0500

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

Wed, 11 Dec 2019 17:22:17 -0500

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

How to Solve the Medtech Value Equation with Quality Data

Thu, 05 Dec 2019 16:47:46 -0500

How to Solve the Medtech Value Equation with Quality Data

Why Supplier Quality Management Is So Important For Medical Device Companies

Wed, 27 Nov 2019 15:38:25 -0500

Why Supplier Quality Management Is So Important For Medical Device Companies

Preparing for EU MDR

Tue, 26 Nov 2019 15:38:29 -0500

Preparing for EU MDR

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

Tue, 26 Nov 2019 15:38:28 -0500

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

Best Practices for Implementing Design Controls for the Medical Device Industry

Thu, 07 Nov 2019 15:07:39 -0500

Best Practices for Implementing Design Controls for the Medical Device Industry

Risk Management from a Regulatory & Product Development Point of View

Thu, 07 Nov 2019 15:07:38 -0500

Risk Management from a Regulatory & Product Development Point of View

How To Improve Your Medical Device Design Reviews

Thu, 07 Nov 2019 15:07:38 -0500

How To Improve Your Medical Device Design Reviews

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

Thu, 07 Nov 2019 15:07:38 -0500

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

How to Improve Your Medical Device Design Reviews Bonus Episode

Thu, 07 Nov 2019 15:07:38 -0500

How to Improve Your Medical Device Design Reviews Bonus Episode

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

Thu, 07 Nov 2019 15:07:37 -0500

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

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

Thu, 07 Nov 2019 15:07:37 -0500

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

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

Thu, 07 Nov 2019 15:07:36 -0500

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

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

Thu, 07 Nov 2019 15:07:36 -0500

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

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

Thu, 07 Nov 2019 15:07:36 -0500

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

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

Thu, 07 Nov 2019 15:07:35 -0500

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

Thu, 07 Nov 2019 15:07:35 -0500

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

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

Thu, 07 Nov 2019 15:07:34 -0500

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

Thu, 07 Nov 2019 15:07:34 -0500

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

Medical Device Product Development Project Management Best Practices with Peter Sebelius

Thu, 07 Nov 2019 15:07:33 -0500

Medical Device Product Development Project Management Best Practices with Peter Sebelius

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

Thu, 07 Nov 2019 15:07:32 -0500

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

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

Thu, 07 Nov 2019 15:07:32 -0500

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

Integrating Business Elements into Your Product Development Process with Therese Graff

Thu, 07 Nov 2019 15:07:31 -0500

Integrating Business Elements into Your Product Development Process with Therese Graff

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Thu, 07 Nov 2019 15:07:31 -0500

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Tips to Help You Prepare for an FDA Inspection

Thu, 07 Nov 2019 15:07:30 -0500

Tips to Help You Prepare for an FDA Inspection

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

Thu, 07 Nov 2019 15:07:30 -0500

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

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

Thu, 07 Nov 2019 15:07:29 -0500

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

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

Thu, 07 Nov 2019 15:07:29 -0500

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

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

Thu, 07 Nov 2019 15:07:28 -0500

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

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

Thu, 07 Nov 2019 15:07:28 -0500

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

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

Thu, 07 Nov 2019 15:07:28 -0500

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

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

Thu, 07 Nov 2019 15:07:27 -0500

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

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

Thu, 07 Nov 2019 15:07:27 -0500

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

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Thu, 07 Nov 2019 15:07:27 -0500

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

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

Thu, 07 Nov 2019 15:07:26 -0500

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

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

Thu, 07 Nov 2019 15:07:26 -0500

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

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

Thu, 07 Nov 2019 15:07:26 -0500

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

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

Thu, 07 Nov 2019 15:07:25 -0500

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

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

Thu, 07 Nov 2019 15:07:25 -0500

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

2016 Medical Device Regulatory Trends Year in Review

Thu, 07 Nov 2019 15:07:24 -0500

2016 Medical Device Regulatory Trends Year in Review

An Overview of What Device Makers Need to Know About CAPA

Thu, 07 Nov 2019 15:07:23 -0500

An Overview of What Device Makers Need to Know About CAPA

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

Thu, 07 Nov 2019 15:07:23 -0500

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

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

Thu, 07 Nov 2019 15:07:23 -0500

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

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

Thu, 07 Nov 2019 15:07:23 -0500

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

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

Thu, 07 Nov 2019 15:07:23 -0500

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

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

Thu, 07 Nov 2019 15:07:22 -0500

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

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

Thu, 07 Nov 2019 15:07:22 -0500

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

Understanding the Connection Between Complaints, CAPAs, and MDRs

Thu, 07 Nov 2019 15:07:21 -0500

Understanding the Connection Between Complaints, CAPAs, and MDRs

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

Thu, 07 Nov 2019 15:07:21 -0500

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

The Intersection of Medical Device Usability and Risk Management

Thu, 07 Nov 2019 15:07:21 -0500

The Intersection of Medical Device Usability and Risk Management

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Thu, 07 Nov 2019 15:07:20 -0500

Understanding FDA’s Proposed Conformity Assessment Pilot Program