Greenlight Guru
3.56K subscribers
1:18:15
10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls)
Greenlight Guru
144 views • 1 month ago
1:01:46
How to Avoid Common Problems with your Design, Risk, and Validation Documentation
Greenlight Guru
92 views • 1 month ago
1:16:04
Pre-Market Medical Device Studies and GCP - Strategies for Success
Greenlight Guru
66 views • 1 month ago
1:16:42
How to Prepare for and Manage Audits/Inspections across Global Markets
Greenlight Guru
61 views • 1 month ago
54:33
Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints
Greenlight Guru
51 views • 1 month ago
1:25:04
Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations
Greenlight Guru
60 views • 1 month ago
1:10:44
Demystifying FDA's Human Factors Guidance
Greenlight Guru
47 views • 1 month ago
1:27:55
5 Key Points to Consider in Design Transfer of MedTech
Greenlight Guru
44 views • 1 month ago
1:31:02
Bridging User Needs & Design Requirements
Greenlight Guru
92 views • 1 month ago
1:34:11
510(k) and Substantial Equivalence: Why Do So Many Get It Wrong?
Greenlight Guru
105 views • 1 month ago
1:30:28
Post-Market Surveillance for Medical Devices & Combination Products
Greenlight Guru
459 views • 5 months ago
1:15:21
How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls
Greenlight Guru
333 views • 5 months ago
1:29:31
Refuse to Accept & Additional Information Request: Avoiding Problems with Medical Device Submissions
Greenlight Guru
76 views • 5 months ago
56:02
Demystifying FDA’s Pre-Market Final Guidance
Greenlight Guru
199 views • 5 months ago
1:28:05
Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent
Greenlight Guru
181 views • 5 months ago
1:05:23
10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR
Greenlight Guru
262 views • 6 months ago
1:31:15
Change Management and Risk Management: How Do We Connect the Dots and What Happens if We Don’t?
Greenlight Guru
122 views • 6 months ago
1:20:22
Bridging the Gap Between Development and Regulatory Teams
Greenlight Guru
133 views • 6 months ago
1:05:20
How to Apply Risk Management Throughout the Product Lifecycle of Your Medical Device
Greenlight Guru
426 views • 6 months ago
1:20:11
Preparing Your Technical Documentation under MDR: Proven Tips & Techniques
Greenlight Guru
590 views • 6 months ago
44:58
Developing IEC 62304 Compliant Software: Proven Tips & Best Practices
Greenlight Guru
387 views • 6 months ago
1:15:30
How to Survive an FDA Inspection
Greenlight Guru
175 views • 6 months ago
59:37
Alternatives to PMCF Clinical Investigations
Greenlight Guru
115 views • 6 months ago
1:30:26
Understanding the Medical Device Classification System
Greenlight Guru
429 views • 7 months ago
1:30:12
Letter to File 101: Are You Sure You're Preparing Yours Correctly?
Greenlight Guru
207 views • 7 months ago
1:31:24
Usability Testing: Why Can’t We Get It Right?
Greenlight Guru
195 views • 7 months ago
1:08:14
How and When to Register EU Medical Devices and Report UDI Information to EUDAMED
Greenlight Guru
586 views • 7 months ago
58:05
When Design Input Requirements Go Wrong
Greenlight Guru
296 views • 7 months ago
59:23
Prepping your QMS for EU MDR
Greenlight Guru
234 views • 7 months ago
1:18:37
How to Use Clinical Data for Medical Device Submissions in both EU & US
Greenlight Guru
140 views • 7 months ago
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