Global Medical Device Podcast powered by Greenlight Guru
By Greenlight Guru + Medical Device Entrepreneurs
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Category: Medicine
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Subscribers: 92
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Episodes: 350
Description
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
| Episode | Date |
|---|---|
|
#365: Medical Device Reporting: The Do's and Don'ts
|
May 02, 2024 |
|
#364: Building a Partnership with your Regulatory Consultant
|
Apr 30, 2024 |
|
#363: Bringing a Self-Funded Medical Device to Market
|
Apr 25, 2024 |
|
#362: Managing Risk in Clinical Investigations
|
Apr 23, 2024 |
|
#361: Speaking the Language of IVD
|
Apr 19, 2024 |
|
#360: Is It Possible to "Buy" a QMS?
|
Apr 13, 2024 |
|
#359: Project Management in MedTech
|
Apr 04, 2024 |
|
#358: FDAs Voluntary Improvement Program
|
Mar 21, 2024 |
|
#357: The State of UDI Across the World
|
Mar 07, 2024 |
|
#356: Quality Myths & Lessons Learned Part II
|
Feb 22, 2024 |
|
#355: Mastering the Pitch: MedTech Innovations from Concept to Market
|
Feb 15, 2024 |
|
#354: Advice for MedTech Regulatory Affairs Professionals
|
Feb 07, 2024 |
|
#353: How Artificial Intelligence is Impacting the MedTech Industry
|
Jan 30, 2024 |
|
#352: Fundamentals of Quality & Regulatory
|
Jan 18, 2024 |
|
#351: The State of AI & Clinical Investigations
|
Jan 11, 2024 |
|
#350: The Evolving Landscape of AI in MedTech
|
Jan 04, 2024 |
|
#349: Climbing the MedTech Career Ladder - How to Get to the Top
|
Dec 21, 2023 |
|
#348: Considerations for IVD
|
Dec 14, 2023 |
|
#347: Human-Centered Design in Medical Devices
|
Dec 07, 2023 |
|
#346: FDAs eSTAR Program
|
Nov 30, 2023 |
|
#345: Using AI In MedTech
|
Nov 22, 2023 |
|
#344: Becoming an Advisor to a Medical Device Company
|
Nov 16, 2023 |
|
#343: Recent FDA Draft Guidances
|
Nov 09, 2023 |
|
#342: Planning an FDA Submission
|
Nov 02, 2023 |
|
#341: What NOT to say to FDA
|
Oct 25, 2023 |
|
#340: LDTs & the FDAs Proposed Ruling
|
Oct 19, 2023 |
|
#339: UDI and the State of EUDAMED
|
Oct 12, 2023 |
|
#338: Site Selection for Clinical Trials
|
Oct 06, 2023 |
|
#337: Moving MedTech Forward - The Past, Present & Future of Greenlight Guru
|
Sep 21, 2023 |
|
#336: From Academia to FDA Clearance (True Quality Roadshow - Boston)
|
Sep 14, 2023 |
|
#335: Accelerating SaMD Development in a Compliant Agile way
|
Sep 08, 2023 |
|
#334: MedTech Funding and Preparing for Due Diligence
|
Aug 31, 2023 |
|
#333: Exploring Breakthrough Device Designation
|
Aug 25, 2023 |
|
#332: Regulatory Strategy and the Advantage of Diversity in MedTech
|
Aug 17, 2023 |
|
#331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues
|
Aug 10, 2023 |
|
#330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?
|
Aug 03, 2023 |
|
#329 The Right Way to Start a QMS: When, How, & What
|
Jul 27, 2023 |
|
#328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices
|
Jul 20, 2023 |
|
#327 Understanding the ROI of an eQMS
|
Jul 11, 2023 |
|
#326 CSA vs. CSV: Modern Validation for Modern MedTech
|
Jul 07, 2023 |
|
#325 The Role of dFMEAs in Risk Management for Medical Devices
|
Jun 30, 2023 |
|
#324 Management Responsibility: The most important part of a QMS
|
Jun 22, 2023 |
|
#323 The Combination Products Handbook
|
Jun 16, 2023 |
|
Leaning into Lean Documentation
|
Jun 07, 2023 |
|
Cybersecurity and the Future of MedTech
|
Jun 02, 2023 |
|
How AI Can Help You Manage Risk
|
May 26, 2023 |
|
Ad Promo and The Difference in Regulatory & Legal
|
May 24, 2023 |
|
The Tools that Make Clinical Investigations
|
May 13, 2023 |
|
Complaint Handling with Medical Device Guru, Brittney McIver
|
May 03, 2023 |
|
Avoiding Potential Issues with your 510(k) Submission
|
Apr 27, 2023 |
|
Meet a Guru: Brittani Smith
|
Apr 20, 2023 |
|
Why Building Supplier Relationships Is So Important
|
Apr 12, 2023 |
|
Systematic Literature Review for EU MDR
|
Apr 05, 2023 |
|
Building Your Design Controls (and Pitfalls to Avoid)
|
Mar 29, 2023 |
|
Most Common Problems Found During FDA Inspections in 2022
|
Mar 23, 2023 |
|
V&V Activities from a Verification Engineer POV - How Hard Could It Be?
|
Mar 15, 2023 |
|
Understanding the 'Compliance Manager' Role
|
Mar 09, 2023 |
|
DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact
|
Mar 02, 2023 |
|
How Communication Affects the Outcomes of Quality Activities
|
Feb 23, 2023 |
|
Part 2: The Theranos Loophole & Lab Developed Tests
|
Feb 16, 2023 |
|
Part 1: The Theranos Loophole & Lab Developed Tests
|
Feb 10, 2023 |
|
Implementing an eQMS after Switching from Paper
|
Feb 02, 2023 |
|
Essentials of Sterilization for Med Device Professionals
|
Jan 26, 2023 |
|
UDI: 101
|
Jan 21, 2023 |
|
Quality Myths and Lessons Learned
|
Jan 19, 2023 |
|
Determining User Needs for Your Medical Device
|
Jan 14, 2023 |
|
Fraud in the Healthcare Industry & the Role of Whistleblowers
|
Jan 12, 2023 |
|
Auditing the Auditor
|
Jan 07, 2023 |
|
What is MedTech Lifecycle Excellence?
|
Jan 05, 2023 |
|
The Best of Jon & Mike Through the Years
|
Dec 29, 2022 |
|
CDRH Proposed Guidance for FY 2023
|
Dec 22, 2022 |
|
Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
|
Dec 15, 2022 |
|
The Future of Healthcare & How We Get There
|
Dec 08, 2022 |
|
What "Exempt" Means with Respect to Medical Devices & Regulatory
|
Nov 30, 2022 |
|
Developing a Regulatory Strategy
|
Nov 23, 2022 |
|
We Achieved ISO Certification! Now What?
|
Nov 17, 2022 |
|
The Future of Reprocessed Used Medical Equipment
|
Nov 11, 2022 |
|
The Importance of Cervical Cancer Screening in the U.S.
|
Nov 04, 2022 |
|
Customer Discovery for Medical Device Companies
|
Nov 02, 2022 |
|
EUA and the Impending Transition
|
Oct 26, 2022 |
|
Common QMS Mistakes SaMD Companies Make
|
Oct 21, 2022 |
|
Design Assurance: The Unsung Heroes of R&D
|
Oct 13, 2022 |
|
Lessons from an Industry Leader: Playing the Long Game of MedTech
|
Oct 06, 2022 |
|
7 Common 510(k) Mistakes and How to Avoid Them
|
Sep 29, 2022 |
|
Best Practices for Clinical Evidence Management
|
Sep 22, 2022 |
|
Building Your Regulatory Strategy for Commercialization
|
Sep 14, 2022 |
|
Packaging Validation Best Practices
|
Sep 07, 2022 |
|
Overcoming Submission Deficiencies due to Biocompatibility
|
Sep 01, 2022 |
|
Does Your CAPA Process Need a CAPA?
|
Aug 24, 2022 |
|
UDI and the Current State of Global Implementation
|
Aug 18, 2022 |
|
The Changing Job Market & How It Affects Careers for MedTech Quality Professionals
|
Aug 10, 2022 |
|
Digitizing your SaMD Testing
|
Aug 03, 2022 |
|
Examining FDA’s Refusal to Accept (RTA) Policy and Guidance
|
Jul 27, 2022 |
|
Guerilla Tactics for Quality Leadership
|
Jul 20, 2022 |
|
Preventing the Death of Medical Device Sales
|
Jul 13, 2022 |
|
Shifting Sands of SaMD Cybersecurity Regulations
|
Jul 06, 2022 |
|
Early Stage Territory Planning for Medical Device Companies
|
Jun 29, 2022 |
|
Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry
|
Jun 22, 2022 |
|
What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?
|
Jun 16, 2022 |
|
Early Feasibility Studies in Latin America
|
Jun 08, 2022 |
|
Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry
|
Jun 01, 2022 |
|
Approaching Cybersecurity & Usability as a SaMD Company
|
May 28, 2022 |
|
The Future of Lateral Flow Test Technology
|
May 25, 2022 |
|
Building a Culture of Quality
|
May 20, 2022 |
|
Bringing Medical Devices into the Home
|
May 18, 2022 |
|
Demystifying the De Novo Process
|
May 12, 2022 |
|
Challenges for Regulatory Submission: EU vs. US
|
May 06, 2022 |
|
From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE
|
May 04, 2022 |
|
The Future of Cybersecurity
|
Apr 30, 2022 |
|
Achieving Operational Readiness through Good Project Management
|
Apr 27, 2022 |
|
Bridging the Gap between Medical Devices and Clinical Data
|
Apr 20, 2022 |
|
Navigating the Medical Device Single Audit Program (MDSAP)
|
Apr 13, 2022 |
|
Bringing Augmented Reality MedTech to Market
|
Apr 07, 2022 |
|
Making Your Informational Meetings with FDA Valuable & Worthwhile
|
Mar 30, 2022 |
|
Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs
|
Mar 23, 2022 |
|
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices
|
Mar 16, 2022 |
|
How Medical Device Intellectual Property Protection Varies by Sector
|
Mar 09, 2022 |
|
Human Factors & Risk Management: What's Needed & Why?
|
Mar 02, 2022 |
|
What are the Opportunities for Improvement (OFI) for Quality?
|
Feb 23, 2022 |
|
Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph
|
Feb 17, 2022 |
|
How to Select a Contract Manufacturer
|
Feb 02, 2022 |
|
A Regulatory Gap Analysis of FDA's Systems & Policies
|
Jan 26, 2022 |
|
Tips for Being Prepared Post-EUA (Emergency Use Authorization)
|
Jan 12, 2022 |
|
Understanding the UDI System for Medical Devices
|
Jan 06, 2022 |
|
Shaking Things Up: What's Next for the Global Medical Device Podcast
|
Dec 16, 2021 |
|
How Augmented Reality (AR) is Revolutionizing Healthcare
|
Dec 09, 2021 |
|
Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care
|
Dec 02, 2021 |
|
Why Usability Matters
|
Nov 24, 2021 |
|
A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology
|
Nov 17, 2021 |
|
What are the Top Compliance Issues Plaguing Medical Device Manufacturers?
|
Nov 10, 2021 |
|
Setting the Record Straight on Usability & Human Factors
|
Nov 03, 2021 |
|
Project Management for Product Development of Medical Devices
|
Oct 27, 2021 |
|
Assessing the Global Regulatory Landscape
|
Oct 21, 2021 |
|
When to Throw the Least Burdensome Flag on FDA
|
Oct 06, 2021 |
|
Past, Present, Future State (and World) of Quality in the Medical Device Industry
|
Sep 22, 2021 |
|
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc
|
Sep 16, 2021 |
|
Addressing the 'Who, What, When' of Quality in the Medical Device Industry
|
Sep 08, 2021 |
|
Meet a Guru: Maryann Mitchell
|
Sep 02, 2021 |
|
Why Storytelling Matters for Medical Device Companies
|
Aug 25, 2021 |
|
A Breakthrough Device that Aims to Prevent Osteoporosis
|
Aug 19, 2021 |
|
Understanding FDA's New Intended Use Rule and its Implications
|
Aug 11, 2021 |
|
eQMS in Academia: Practical Learning for Biomedical Engineering Students
|
Jul 28, 2021 |
|
Tips for Running Better Management Reviews
|
Jul 19, 2021 |
|
Meet a Guru: Ryan Behringer
|
Jul 14, 2021 |
|
Navigating the MedTech Cybersecurity Ecosystem
|
Jul 13, 2021 |
|
Managing Clinical Data Activities
|
Jul 07, 2021 |
|
Explaining the Role of Importer under EU MDR
|
Jul 01, 2021 |
|
Preparing Your Pre-Submission with the Content FDA Wants to See
|
Jun 23, 2021 |
|
How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021
|
Jun 21, 2021 |
|
How New Training Partnership is Advancing Medical Device Knowledge & Professional Development
|
Jun 16, 2021 |
|
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020
|
Jun 14, 2021 |
|
How Mindset Training Can Help Your Team Operate at Peak Performance
|
Jun 09, 2021 |
|
Examining the HHS Proposal for Premarket Notification Exemptions
|
Jun 07, 2021 |
|
Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead
|
Jun 02, 2021 |
|
Building your Brand as a Medical Device Professional
|
May 31, 2021 |
|
Understanding the Value of a Medical Device Guru
|
May 26, 2021 |
|
Meet a Guru: Etienne Nichols
|
May 24, 2021 |
|
Meet a Guru: Laura Court
|
May 19, 2021 |
|
Regulatory Tips & Pointers from a Former FDA Reviewer
|
May 17, 2021 |
|
Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)
|
May 12, 2021 |
|
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program
|
May 11, 2021 |
|
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?
|
May 07, 2021 |
|
Managing Business Risk as a Medical Device Company
|
May 03, 2021 |
|
Waterfall vs. Agile: Battle of the Product Development Methodologies
|
Apr 28, 2021 |
|
For the Love of Internal Auditing
|
Apr 26, 2021 |
|
Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices
|
Apr 21, 2021 |
|
Knowing vs. Doing as Medical Device Professionals
|
Apr 19, 2021 |
|
Pivoting Operations to Meet PPE Demand during Pandemic
|
Apr 14, 2021 |
|
Pros & Cons of Being a Physician turned MedTech Inventor
|
Apr 13, 2021 |
|
3 Systems of Risk for Medical Devices from FDA
|
Apr 07, 2021 |
|
Quality Management for IVD Devices vs Medical Devices
|
Apr 05, 2021 |
|
Understanding the Investigational Device Exemption (IDE) Process
|
Mar 31, 2021 |
|
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry
|
Mar 30, 2021 |
|
Why the PMA Process is so Dreaded by Manufacturers in the US Market
|
Mar 25, 2021 |
|
Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients
|
Mar 24, 2021 |
|
What is the Safer Technologies Program (STeP) and Can Your Device Use It?
|
Mar 21, 2021 |
|
Meet a Guru: Sara Adams
|
Mar 17, 2021 |
|
Building a Startup in the MedTech Industry
|
Mar 10, 2021 |
|
Meet a Guru: Karen Schuyler
|
Mar 08, 2021 |
|
Visualizing a Medical Device through Illustrations, Animations, and other Artwork
|
Mar 04, 2021 |
|
Everything you Need to Know about SaMD from an FDA Perspective
|
Mar 01, 2021 |
|
Preparing for Remote and On-Site Inspections and Audits
|
Feb 24, 2021 |
|
How does EU MDR impact your Quality Management System?
|
Feb 22, 2021 |
|
Virtual Auditing in a Post-COVID World of Digital Compliance
|
Feb 18, 2021 |
|
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View
|
Feb 10, 2021 |
|
Prioritizing Medical Device Reimbursement During Product Development
|
Feb 04, 2021 |
|
5 Actionable Lessons Learned from the RADx Initiative by NIH
|
Jan 27, 2021 |
|
What are the Strategic Priorities for CDRH in 2021?
|
Jan 20, 2021 |
|
Understanding and Handling Different Types of Feedback
|
Jan 14, 2021 |
|
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape
|
Jan 07, 2021 |
|
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry
|
Dec 23, 2020 |
|
Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near
|
Dec 17, 2020 |
|
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?
|
Dec 09, 2020 |
|
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA
|
Dec 02, 2020 |
|
What Goes into Designing Devices for Military and Emergency Applications?
|
Nov 26, 2020 |
|
Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?
|
Nov 18, 2020 |
|
Positive and Negative Impacts of EUA on the Medical Device Industry
|
Nov 12, 2020 |
|
Why Biocompatibility Should be Addressed by Every Medical Device Company
|
Nov 04, 2020 |
|
Meet a Guru: Erica Loring
|
Oct 28, 2020 |
|
What is a Multiple Function Device?
|
Sep 30, 2020 |
|
Challenges related to Home Use Devices
|
Sep 10, 2020 |
|
Submitting a 510(k) using FDA's Safety and Performance Based Pathway
|
Sep 02, 2020 |
|
How Jon Speer Met His Most Frequent Guest: Mike Drues
|
Aug 26, 2020 |
|
Meet a Guru: Wade Schroeder
|
Aug 19, 2020 |
|
What are the Audit Etiquette Rules I Should be Following?
|
Aug 12, 2020 |
|
Meet a Guru: Tom Rish
|
Aug 05, 2020 |
|
Addressing Clinical Trial Challenges & Concerns during COVID-19
|
Jul 29, 2020 |
|
Protecting the Intellectual Property of your Medical Device Technology
|
Jul 22, 2020 |
|
Meet a GURU: Jesseca Lyons
|
Jul 15, 2020 |
|
How to Build a QMS for a Medical Device
|
Jul 08, 2020 |
|
Meet a Guru: Taylor Brown
|
Jul 01, 2020 |
|
What is Regulatory Due Diligence for Medical Devices?
|
Jun 24, 2020 |
|
Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief
|
Jun 17, 2020 |
|
How Being Strategic During A Career Transition Can Yield The Best Opportunities
|
Jun 11, 2020 |
|
Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry
|
Jun 03, 2020 |
|
How to Construct an Effective Regulatory Strategy
|
May 27, 2020 |
|
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)
|
May 20, 2020 |
|
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices
|
May 13, 2020 |
|
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies
|
May 06, 2020 |
|
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers
|
Apr 29, 2020 |
|
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem
|
Apr 22, 2020 |
|
How to Approach Verification and Validation for Cloud Software
|
Apr 15, 2020 |
|
Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives
|
Apr 10, 2020 |
|
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know
|
Apr 08, 2020 |
|
How to Integrate Usability into your Medical Device
|
Apr 01, 2020 |
|
[LIVE] Design Controls, Development & Risk for Software as a Medical Device (SaMD)
|
Mar 26, 2020 |
|
How to Leverage IEC 62304 to Improve SaMD Development Processes
|
Mar 18, 2020 |
|
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?
|
Mar 12, 2020 |
|
How to Choose the Right FDA Regulatory Pathway for your Device
|
Feb 26, 2020 |
|
How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory
|
Feb 19, 2020 |
|
4 Parts to Interviewing Candidates for Medical Device Roles
|
Feb 13, 2020 |
|
5 Tips for Hiring Medical Device Advisors
|
Feb 05, 2020 |
|
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020
|
Jan 29, 2020 |
|
Navigating the Twists and Turns of Change Management for Medical Devices
|
Dec 28, 2019 |
|
What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?
|
Dec 19, 2019 |
|
5 Myths about QA/RA Recruiting in the Medical Device Industry
|
Dec 11, 2019 |
|
How to Solve the Medtech Value Equation with Quality Data
|
Dec 05, 2019 |
|
Why Supplier Quality Management Is So Important For Medical Device Companies
|
Nov 27, 2019 |
|
Preparing for EU MDR
|
Nov 26, 2019 |
|
FDA is Expanding its Case for Quality Program... Should Your Company Participate?
|
Nov 26, 2019 |
|
Best Practices for Implementing Design Controls for the Medical Device Industry
|
Nov 07, 2019 |
|
How to Improve Your Medical Device Design Reviews Bonus Episode
|
Nov 07, 2019 |
|
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?
|
Nov 07, 2019 |
|
How To Improve Your Medical Device Design Reviews
|
Nov 07, 2019 |
|
Risk Management from a Regulatory & Product Development Point of View
|
Nov 07, 2019 |
|
Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's
|
Nov 07, 2019 |
|
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken
|
Nov 07, 2019 |
|
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson
|
Nov 07, 2019 |
|
How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues
|
Nov 07, 2019 |
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How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans
|
Nov 07, 2019 |
|
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey
|
Nov 07, 2019 |
|
Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor
|
Nov 07, 2019 |
|
An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson
|
Nov 07, 2019 |
|
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner
|
Nov 07, 2019 |
|
Medical Device Product Development Project Management Best Practices with Peter Sebelius
|
Nov 07, 2019 |
|
Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong
|
Nov 07, 2019 |
|
The Difference Between Intended Use and Indications of Use with Mike Drues
|
Nov 07, 2019 |
|
How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso
|
Nov 07, 2019 |
|
Integrating Business Elements into Your Product Development Process with Therese Graff
|
Nov 07, 2019 |
|
What Device Makers Need to Know About Design Verification and Validation with Mike Drues
|
Nov 07, 2019 |
|
Tips to Help You Prepare for an FDA Inspection
|
Nov 07, 2019 |
|
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?
|
Nov 07, 2019 |
|
Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner
|
Nov 07, 2019 |
|
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development
|
Nov 07, 2019 |
|
Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer
|
Nov 07, 2019 |
|
How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues
|
Nov 07, 2019 |
|
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose
|
Nov 07, 2019 |
|
Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues
|
Nov 07, 2019 |
|
Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations
|
Nov 07, 2019 |
|
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)
|
Nov 07, 2019 |
|
Understanding the New FDA Guidance on Changes to 510(k)
|
Nov 07, 2019 |
|
Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology
|
Nov 07, 2019 |
|
Tips for Success When It Comes to IEC 60601 with Leo Eisner
|
Nov 07, 2019 |
|
Using the Bucket Method for Medical Device Risk Management w/ Mike Drues
|
Nov 07, 2019 |
|
2016 Medical Device Regulatory Trends Year in Review
|
Nov 07, 2019 |
|
How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia
|
Nov 07, 2019 |
|
What Devicemakers Need to Know About Medical Device Reporting (MDR)
|
Nov 07, 2019 |
|
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
|
Nov 07, 2019 |
|
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance
|
Nov 07, 2019 |
|
An Overview of What Device Makers Need to Know About CAPA
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Nov 07, 2019 |
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How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster
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Nov 07, 2019 |
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How FDA Interacts with Medical Devices When They Are Imported into the US
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Nov 07, 2019 |
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The Intersection of Medical Device Usability and Risk Management
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Nov 07, 2019 |
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When Design Inputs Go Wrong + Design Your Label Like You Design Your Device
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Nov 07, 2019 |
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Understanding the Connection Between Complaints, CAPAs, and MDRs
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Nov 07, 2019 |
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Understanding the Difference Between a General Wellness Device and a Regulated Medical Device
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Nov 07, 2019 |
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Understanding FDA’s Proposed Conformity Assessment Pilot Program
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Nov 07, 2019 |
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How Process Excellence Leads to Product Excellence
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Nov 07, 2019 |
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Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission
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Nov 07, 2019 |
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How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy
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Nov 07, 2019 |
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Why the 510(k) Process Is So Stressful & How You Can Help Streamline It
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Nov 07, 2019 |
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Lessons to Be Learned From Recent FDA Inspections
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Nov 07, 2019 |
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Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions
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Nov 07, 2019 |
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Common Mistakes That Can Tank Your FDA 510(k) Submission
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Nov 07, 2019 |
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Challenges with Applying Risk Management Throughout the Manufacturing Process
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Nov 07, 2019 |
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An Overview of What Medical Device Developers Need to Know About Human Factors
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Nov 07, 2019 |
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Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway
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Nov 07, 2019 |
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What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important
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Nov 07, 2019 |
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How to Determine the Operational Quality of a Quality System Using a Performance Assessment
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Nov 07, 2019 |
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5 Most Common Problems With Your CAPA Process
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Nov 07, 2019 |
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How to Ensure Your Quality Management System is Effective and Benefits Patients
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Nov 07, 2019 |
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Helping Prepare Biomedical Engineers Entering the Workforce
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Nov 07, 2019 |
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Tips, Tricks & Best Practices for Complying with ISO 13485:2016
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Nov 07, 2019 |
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Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)
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Nov 07, 2019 |
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How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage
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Nov 07, 2019 |
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FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?
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Nov 07, 2019 |
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How to Design for Compliance with IEC 60601
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Nov 07, 2019 |
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How to Think About Quality and Regulatory as Your Company Scales
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Nov 07, 2019 |
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How Human Factors Impact Your Medical Device
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Nov 07, 2019 |
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AI Explainability: What that Means and Why it Matters in the Medical Device Industry
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Nov 07, 2019 |
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The Bleeding Edge: Lessons Learned for the Medical Device Industry
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Nov 07, 2019 |
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What are the Regulatory Expectations for Software as a Medical Device (SaMD)?
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Nov 07, 2019 |
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What you Need to Know about FDA's Progressive Programs
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Nov 07, 2019 |
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How to Embrace Risk for Safer Devices
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Nov 07, 2019 |
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15 Habits of Highly Effective Regulatory Professionals
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Nov 07, 2019 |
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Latest Updates on CDRH Standards Program & IEC 60601
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Nov 07, 2019 |
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What You Need to Know About The FDA CDRH Experiential Learning Program
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Nov 07, 2019 |
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Questions to Ask Before Hiring Your QA/RA Consultant
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Nov 07, 2019 |
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Regulatory Tips & Observations from a Former FDA Reviewer
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Nov 07, 2019 |
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7 Habits of Highly Effective True Quality Medical Device Professionals
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Nov 07, 2019 |
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How to Efficiently Raise Funds for Your Medical Device Company
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Nov 07, 2019 |
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What's New With PMAs
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Nov 07, 2019 |
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The New Special 510(k)
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Nov 07, 2019 |
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Streamlining The Device Marketing Authorization Process
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Nov 07, 2019 |
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Understanding The Differences Between Clearance vs Approval vs Granted
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Nov 07, 2019 |
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Understanding the Blurred Lines Between Consumer Tech and MedTech
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Nov 07, 2019 |
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FDA Plans to Modernize 510(k) - Is the Sky Falling?
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Nov 07, 2019 |
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Medical Device Industry Predictions for 2019
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Nov 07, 2019 |
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Explaining the Significance of Voluntary Consensus Standards
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Nov 07, 2019 |
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Aligning True Quality and Compliance with MDDAP
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Nov 07, 2019 |
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Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?
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Nov 07, 2019 |
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Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies
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Nov 07, 2019 |
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Medical Device Product Development Value Proposition
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Nov 07, 2019 |
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Design Validation vs. Human Factors Validation
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Nov 07, 2019 |
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Who Should Own Your QMS?
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Nov 07, 2019 |
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How and When to Consider Human Factors
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Nov 07, 2019 |
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Nonbinding Feedback is a New Guidance You Should Know About
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Nov 07, 2019 |
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Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway
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Nov 07, 2019 |
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Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices
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Nov 07, 2019 |
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Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm
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Nov 07, 2019 |
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The 100th Episode: A Few of My Favorite Moments
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Nov 07, 2019 |
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How to Make De Novo a Viable Option for your Medical Device
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Nov 07, 2019 |
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Biocompatibility Nuances and its Impact on Medical Devices
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Nov 07, 2019 |
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EU MDR: Not All Doom and Gloom
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Nov 07, 2019 |
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Greenlight Guru In the Classroom: A University's Real-world Approach
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Nov 07, 2019 |
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Integrating Human Factors into Design Controls to Improve Patient Outcomes
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Nov 07, 2019 |
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Is Your Medical Device Company CAPA Happy?
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Nov 07, 2019 |
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Challenges with MedTech Innovation
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Nov 07, 2019 |
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Looking at the Sunset of FDA's Alternative Summary Reporting Program
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Nov 07, 2019 |
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Importance of Software Requirements in Product Development
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Nov 07, 2019 |