Greenlight Guru
10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls)
1:18:15
Greenlight Guru
How to Avoid Common Problems with your Design, Risk, and Validation Documentation
1:01:46
Greenlight Guru
Pre-Market Medical Device Studies and GCP - Strategies for Success
1:16:04
Greenlight Guru
How to Prepare for and Manage Audits/Inspections across Global Markets
1:16:42
Greenlight Guru
Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints
54:33
Greenlight Guru
Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations
1:25:04
Greenlight Guru
Demystifying FDA's Human Factors Guidance
1:10:44
Greenlight Guru
5 Key Points to Consider in Design Transfer of MedTech
1:27:55
Greenlight Guru
Bridging User Needs & Design Requirements
1:31:02
Greenlight Guru
510(k) and Substantial Equivalence: Why Do So Many Get It Wrong?
1:34:11
Greenlight Guru
Post-Market Surveillance for Medical Devices & Combination Products
1:30:28
Greenlight Guru
How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls
1:15:21
Greenlight Guru
Refuse to Accept & Additional Information Request: Avoiding Problems with Medical Device Submissions
1:29:31
Greenlight Guru
Demystifying FDA’s Pre-Market Final Guidance
56:02
Greenlight Guru
Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent
1:28:05
Greenlight Guru
10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR
1:05:23
Greenlight Guru
Change Management and Risk Management: How Do We Connect the Dots and What Happens if We Don’t?
1:31:15
Greenlight Guru
Bridging the Gap Between Development and Regulatory Teams
1:20:22
Greenlight Guru
How to Apply Risk Management Throughout the Product Lifecycle of Your Medical Device
1:05:20
Greenlight Guru
Preparing Your Technical Documentation under MDR: Proven Tips & Techniques
1:20:11
Greenlight Guru
Developing IEC 62304 Compliant Software: Proven Tips & Best Practices
44:58
Greenlight Guru
How to Survive an FDA Inspection
1:15:30
Greenlight Guru
Alternatives to PMCF Clinical Investigations
59:37
Greenlight Guru
Understanding the Medical Device Classification System
1:30:26
Greenlight Guru
Letter to File 101: Are You Sure You're Preparing Yours Correctly?
1:30:12
Greenlight Guru
Usability Testing: Why Can’t We Get It Right?
1:31:24
Greenlight Guru
How and When to Register EU Medical Devices and Report UDI Information to EUDAMED
1:08:14
Greenlight Guru
When Design Input Requirements Go Wrong
58:05
Greenlight Guru
Prepping your QMS for EU MDR
59:23
Greenlight Guru
How to Use Clinical Data for Medical Device Submissions in both EU & US
1:18:37
Greenlight Guru
Evaluating the Need for Biocompatibility Testing & Mitigating Risks when Changing a Medical Device
1:27:35
Greenlight Guru
How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device
1:23:14
Greenlight Guru
Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers
1:29:01
Greenlight Guru
Demonstrating Conformity to General Safety and Performance Requirements GSPR under MDR
44:08
Greenlight Guru
UDI Product Data and EUDAMED, Get Onboard!
1:32:00
Greenlight Guru
Insider’s Look at the IEC 60601 Amendments: Guidance from Committee Member Responsible for Changes
1:23:02
Greenlight Guru
The “New” 510(k): How Do You Show Substantial Equivalence without Using a Predicate?
1:25:43
Greenlight Guru
EU MDR: How Do I Interpret The New Regulations and What Do I Need to Do to Be Compliant?
1:10:58
Greenlight Guru
Verification & Testing Strategies for Compliance with ISO 13485:2016 & IEC 62304, 60601-1, 82304-1
1:06:05
Greenlight Guru
QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance
1:24:26
Greenlight Guru
An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019
1:31:56
Greenlight Guru
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Reactive
1:01:59
Greenlight Guru
Why Design Validation Is More Than Testing: How Do We Validate Our Validation
1:27:18
Greenlight Guru
Greenlight Guru Clinical | EDC Software Overview
4:08
Greenlight Guru
Greenlight Guru Quality | QMS Software Overview
6:25
Greenlight Guru
Greenlight Guru: Moving MedTech Forward
1:43
Greenlight Guru
The Combination Products Handbook
39:22
Greenlight Guru
Leaning into Lean Documentation
48:03
Greenlight Guru
Cybersecurity and the Future of MedTech
1:00:01
Greenlight Guru
Ad Promo and The Difference in Regulatory & Legal
55:36
Greenlight Guru
How AI Can Help You Manage Risk
32:44
Greenlight Guru
The Tools that Make Clinical Investigations
31:51
Greenlight Guru
Complaint Handling with Medical Device Guru, Brittney McIver
30:25
Greenlight Guru
Avoiding Potential Issues with your 510(k) Submission
39:56
Greenlight Guru
Meet a Guru, Brittani Smith
26:20
Greenlight Guru
Why Building Supplier Relationships Is So Important
29:12
Greenlight Guru
Systematic Literature Review for EU MDR
31:49
Greenlight Guru
Building Your Design Controls (and Pitfalls to Avoid)
31:29
Greenlight Guru
Most Common Problems Found During FDA Inspections in 2022
41:06
Greenlight Guru
Guru Edge: Verification & Validation - How Hard Could It Be?
30:43
Greenlight Guru
Understanding the 'Compliance Manager' Role
20:13
Greenlight Guru
DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact
26:39
Greenlight Guru
How Communication Affects the Outcomes of Quality Activities
47:22
Greenlight Guru
Part 2: The Theranos Loophole & Lab Developed Tests
42:04
Greenlight Guru
Part 1: The Theranos Loophole & Lab Developed Tests
36:33
Greenlight Guru
The Compliance Concern: Challenges and Roadblocks for Ensuring Compliance in 2023
55:25
Greenlight Guru
How Electronic Data Capture Is Transforming the MedTech Industry
50:04
Greenlight Guru
The ROI of Shifting Mindset From Compliance to Quality
50:32
Greenlight Guru
Leveraging Modern Software Technologies: MedTech’s Best Kept Secret
45:39
Greenlight Guru
Behind the Stats: Expectations vs. Reality of Bringing a Device to Market
47:25
Greenlight Guru
Implementing an eQMS after Switching from Paper
29:46
Greenlight Guru
The Essentials of Sterilization
35:50
Greenlight Guru
UDI: 101
30:09
Greenlight Guru
Quality Myths and Lessons Learned
44:35
Greenlight Guru
Determining User Needs for Your Medical Device
37:27
Greenlight Guru
Fraud in the Healthcare Industry & the Role of Whistleblowers
51:45
Greenlight Guru
Auditing the Auditor
35:35
Greenlight Guru
What is MedTech Lifecycle Excellence?
36:00
Greenlight Guru
The Best of Jon & Mike Through the Years
44:15
Greenlight Guru
CDRH Proposed Guidance for FY 2023
39:15
Greenlight Guru
Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
39:16
Greenlight Guru
The Future of Healthcare & How We Get There
42:39
Greenlight Guru
What "Exempt" Means with Respect to Medical Devices & Regulatory
44:30
Greenlight Guru
Developing a Regulatory Strategy
38:43
Greenlight Guru
Common Misconceptions on Medical Device Risk & Design Controls
51:14
Greenlight Guru
QMSR Harmonization: The Future of FDA's Quality Management System Regulation
50:49
Greenlight Guru
QMS from a Regulatory Perspective
45:27
Greenlight Guru
Modernizing your QMS to keep up with the Modern Age of Requirements
46:09
Greenlight Guru
eMDR Program and Process
44:46
Greenlight Guru
Moving up to the State of the Art in Risk Management
50:16
Greenlight Guru
ISO 13485: What's Next?
44:31
Greenlight Guru
Computer Software Assurance (CSA): Understanding the FDA’s New Draft Guidance
48:41
Greenlight Guru
We achieved ISO certification! Now what?
37:47
Greenlight Guru
The Future of Reprocessed Used Medical Equipment
40:06
Greenlight Guru
The importance of cervical cancer screening in the U.S.
19:47
Greenlight Guru
Customer Discovery for Medical Device Companies
36:14
Greenlight Guru
EUA and the Impending Transition
36:20
Greenlight Guru
Common QMS Mistakes SaMD Companies Make
42:39
Greenlight Guru
Design Assurance: The Unsung Heroes of R&D
41:38
Greenlight Guru
Lessons from an Industry Leader: Playing the Long Game of MedTech
1:47:54