Episodes
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
41:02 | 05.11.2021
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?
38:03 | 05.06.2021
Managing Business Risk as a Medical Device Company
34:25 | 05.03.2021
Waterfall vs. Agile: Battle of the Product Development Methodologies
38:29 | 04.28.2021
For the Love of Internal Auditing
33:27 | 04.26.2021
Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices
34:09 | 04.21.2021
Knowing vs. Doing as Medical Device Professionals
31:46 | 04.19.2021
Pivoting Operations to Meet PPE Demand during Pandemic
27:31 | 04.14.2021
Pros & Cons of Being a Physician turned MedTech Inventor
49:07 | 04.13.2021
3 Systems of Risk for Medical Devices from FDA
39:47 | 04.07.2021
Quality Management for IVD Devices vs Medical Devices
41:48 | 04.05.2021
Understanding the Investigational Device Exemption (IDE) Process
57:01 | 03.31.2021
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
37:14 | 03.24.2021
What is the Safer Technologies Program (STeP) and Can Your Device Use It?
32:47 | 03.21.2021
Meet a Guru: Sara Adams
20:22 | 03.17.2021
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
29:59 | 03.10.2021
Meet a Guru: Karen Schuyler
25:50 | 03.08.2021
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
46:12 | 03.01.2021
Preparing for Remote and On-Site Inspections and Audits
50:34 | 02.24.2021
How does EU MDR impact your Quality Management System?
36:02 | 02.22.2021
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
40:10 | 02.10.2021
Prioritizing Medical Device Reimbursement During Product Development
40:48 | 02.03.2021
5 Actionable Lessons Learned from the RADx Initiative by NIH
47:52 | 01.27.2021
What are the Strategic Priorities for CDRH in 2021?
46:47 | 01.20.2021
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
44:08 | 01.06.2021
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
31:17 | 12.16.2020
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
31:25 | 12.02.2020
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?
35:28 | 11.18.2020
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
48:36 | 11.04.2020
Meet a Guru: Erica Loring
38:19 | 10.27.2020
What is a Multiple Function Device?
41:05 | 09.30.2020
Challenges related to Home Use Devices
30:54 | 09.10.2020
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
40:50 | 08.26.2020
Meet a Guru: Wade Schroeder
26:06 | 08.19.2020
What are the Audit Etiquette Rules I Should be Following?
36:21 | 08.12.2020
Meet a Guru: Tom Rish
29:27 | 08.05.2020
Addressing Clinical Trial Challenges & Concerns during COVID-19
38:43 | 07.29.2020
Protecting the Intellectual Property of your Medical Device Technology
39:23 | 07.22.2020
Meet a GURU: Jesseca Lyons
36:57 | 07.15.2020
How to Build a QMS for a Medical Device
44:16 | 07.08.2020
Meet a Guru: Taylor Brown
43:04 | 07.01.2020
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
32:56 | 06.17.2020
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
42:45 | 06.03.2020
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)
36:49 | 05.20.2020
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
43:42 | 05.06.2020
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](https://files.casted.us/e01b1fd1-e743-4260-ad88-0aabb06f20b6.jpg)
[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
39:18 | 04.15.2020
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
45:06 | 04.08.2020
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)](https://files.casted.us/d6420357-bf3f-4e94-bb41-a11f34f6be4f.jpg)
[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
37:00 | 03.18.2020
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
38:45 | 02.26.2020
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
34:10 | 02.12.2020
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
37:11 | 01.29.2020
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?
33:21 | 12.18.2019
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
32:32 | 12.05.2019
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?
36:40 | 11.26.2019
Preparing for EU MDR
30:41 | 11.26.2019
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?
33:43 | 11.07.2019
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
39:24 | 11.07.2019
Why Design Verification Matters in Medical Device Design and Development
40:35 | 11.07.2019
Implementing Changes to SaMD under New EU MDR
37:21 | 11.07.2019
Career Tips for QA/RA Professionals in the Medical Device Industry
30:11 | 11.07.2019
Right-sizing your QMS
38:22 | 11.07.2019
Challenges with Pediatric Medical Devices
30:59 | 11.07.2019
When Should You Start a QMS?
30:44 | 11.07.2019
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
41:24 | 11.07.2019
Importance of Software Requirements in Product Development
32:09 | 11.07.2019
4 Facts That May Surprise You About FDA
29:48 | 11.07.2019
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
39:01 | 11.07.2019
Challenges with MedTech Innovation
34:11 | 11.07.2019
Is Your Medical Device Company CAPA Happy?
34:56 | 11.07.2019
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
35:35 | 11.07.2019
EU MDR: Not All Doom and Gloom
32:06 | 11.07.2019
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
37:54 | 11.07.2019
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
36:46 | 11.07.2019
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
38:33 | 11.07.2019
Nonbinding Feedback is a New Guidance You Should Know About
37:31 | 11.07.2019
How and When to Consider Human Factors
33:46 | 11.07.2019
Who Should Own Your QMS?
23:44 | 11.07.2019
Design Validation vs. Human Factors Validation
34:19 | 11.07.2019
Medical Device Product Development Value Proposition
32:33 | 11.07.2019
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?
32:16 | 11.07.2019
Aligning True Quality and Compliance with MDDAP
37:37 | 11.07.2019
Explaining the Significance of Voluntary Consensus Standards
30:05 | 11.07.2019
Medical Device Industry Predictions for 2019
15:30 | 11.07.2019
FDA Plans to Modernize 510(k) - Is the Sky Falling?
31:59 | 11.07.2019
Understanding the Blurred Lines Between Consumer Tech and MedTech
33:57 | 11.07.2019
Understanding The Differences Between Clearance vs Approval vs Granted
31:52 | 11.07.2019
Streamlining The Device Marketing Authorization Process
38:02 | 11.07.2019
The New Special 510(k)
44:39 | 11.07.2019
What's New With PMAs
43:45 | 11.07.2019
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
43:36 | 11.07.2019
Regulatory Tips & Observations from a Former FDA Reviewer
31:59 | 11.07.2019
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
31:13 | 11.07.2019
Latest Updates on CDRH Standards Program & IEC 60601
45:12 | 11.07.2019
15 Habits of Highly Effective Regulatory Professionals
42:45 | 11.07.2019
How to Embrace Risk for Safer Devices
35:54 | 11.07.2019
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)?
34:27 | 11.07.2019
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
32:21 | 11.07.2019
How Human Factors Impact Your Medical Device
42:56 | 11.07.2019
How to Think About Quality and Regulatory as Your Company Scales
37:55 | 11.07.2019
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?
31:19 | 11.07.2019
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)
40:01 | 11.07.2019
Tips, Tricks & Best Practices for Complying with ISO 13485:2016
27:45 | 11.07.2019
Helping Prepare Biomedical Engineers Entering the Workforce
32:56 | 11.07.2019
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
39:26 | 11.07.2019
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
34:17 | 11.07.2019
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
35:54 | 11.07.2019
Challenges with Applying Risk Management Throughout the Manufacturing Process
21:09 | 11.07.2019
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
35:45 | 11.07.2019
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
30:35 | 11.07.2019
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
32:25 | 11.07.2019
How Process Excellence Leads to Product Excellence
30:56 | 11.07.2019
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
31:23 | 11.07.2019
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
28:05 | 11.07.2019
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
30:56 | 11.07.2019
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
37:45 | 11.07.2019
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?
34:12 | 11.07.2019
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
31:49 | 11.07.2019
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
33:57 | 11.07.2019
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
21:56 | 11.07.2019
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)
32:57 | 11.07.2019
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
32:11 | 11.07.2019
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
30:34 | 11.07.2019
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
31:45 | 11.07.2019
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?
27:33 | 11.07.2019
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
31:21 | 11.07.2019
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
27:10 | 11.07.2019
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
27:16 | 11.07.2019
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
27:30 | 11.07.2019
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
26:14 | 11.07.2019
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
25:42 | 11.07.2019
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
30:10 | 11.07.2019
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
21:24 | 11.07.2019
Risk Management from a Regulatory & Product Development Point of View
22:56 | 11.07.2019
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?
25:09 | 11.07.2019
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
17:45 | 11.07.2019