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Ultimate Guide to Comparing Quality Management System Solutions

Webinars

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EU MDR Hot Takes: Evolution or Overreach?

Live with FDA: Accelerating a Quality Culture at Your Medical Device Company

Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends

From LDTs to IVDs: Navigating the New Regulatory Landscape

Strategies for Navigating the EU MDR Extension Deadlines

Enhancing Clinical Data Collection with Greenlight Guru Clinical's Add-ons

Decoding 'Sufficient Clinical Evidence' under EU MDR for Medical Devices

Enhancing Post-Market Activities with Greenlight Guru’s Quality Event Workflows

IEC 62366-1 Essentials: Elevating User Safety in Medical Devices

Revolutionizing Medical Device Trials with Risk-Based Monitoring

Mastering Document and Change Management with Greenlight Guru Quality

Designing Effective PMCF Surveys in Greenlight Guru Clinical

Conducting Effective FDA Pre-Sub Meetings: Best Practices to Avoid Timely & Costly Mistakes

Live Q&A with FDA: Cybersecurity Premarket Guidance

Key Expectations for ISO 14971 Compliance with Implementation of QMSR

QMSR Final Rule: Meeting FDA’s New Requirements

Insights from TÜV SÜD and Greenlight Guru on the Requirements of PMCF under the MDR 2017/745

Leveraging Automated Training with Greenlight Guru Quality

eSTAR 5.0: Are You Ready?

Significant Risk vs. Nonsignificant Risk Devices: What’s the Difference & Why Does It Matter?

Integrating Risk Management Throughout the Entire Device Lifecycle with Greenlight Guru Quality

Streamline Your Clinical Data Management with Greenlight Guru Clinical's Reporting Module

Key Elements to Outsourcing Clinical Activities in 2024

UDI Product Data and EUDAMED, Get Onboard!

2024 Revealed: Discover What’s New and What’s Next for Greenlight Guru

Achieving Real-Time Audit Readiness Using Greenlight Guru Quality

Integrating eCRF and ePRO in One Single Platform

Demystifying FDA’s Pre-Market Final Guidance

Maximizing Clinician Participation in Post-Market Operations

Streamlining Your Medical Device Development with Greenlight Guru QMS: Live Demo

Mastering Medical Device Audits: A Proven Formula

Best Practices for Patient Recruitment in MedTech Clinical Studies

How Quality & Regulatory Compliance Drive Financial Performance in MedTech

Upgrading Your QMS Solution: Practical Tips & Tricks for a Seamless Transition

Demonstrating Conformity to General Safety and Performance Requirements (GSPR) under MDR

How to Boost Patient Recruitment in Greenlight Guru Clinical

Align Your Clinical Claims with the Clinical Investigation Performance and Safety Endpoints

Complaint Handling: How to Avoid the #3 Most Cited Reason for 483 Observations

Live eCRF Setup and Forms Building in Greenlight Guru Clinical

Data Management and Monitoring in MedTech Clinical Studies

QSR to QMSR: The Rewrite of 21 CFR Part 820 & Key Considerations for FDA Compliance

Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity

How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension

How to Design the Optimal eCRF for Clinical Investigations

Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market

Understanding the ROI of an eQMS Solution

Pre-Market Medical Device Studies and GCP - Strategies for Success

Implementing Risk Throughout the Entire Product Lifecycle

The Ugly Truth About Paper-Based QMS - Making the Switch to eQMS

How To Gain Better Access to Healthcare Decision Makers

How to Show ROI on Your Clinical Evidence

Modernizing Your QMS to Reduce Risk, Improve Quality & Drive Innovation

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

MDR by the Numbers: Leveraging New Data for Implementation Planning

Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

5 Tips for Designing a Medical Device Study under US FDA Requirements

How to Use Clinical Data for Medical Device Submissions in both EU & US

Mastering the Design Transfer Process

Best Practices for Structuring Clinical Data in Medical Device Studies

FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?

Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

Monetizing Software: The Challenges of Commercialization & How to Overcome Them

How to Prepare for IVDR

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

Usability Testing: Why can’t we get it right?

Connecting Computer System Validation to Daily Operations

How to Ensure Your State of Affairs for EU MDR is State of the Art

MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

How to Prepare for the FDA Pre-Submission Process - Free Webinar

Bridging the Gap Between Development and Regulatory Teams

How to Survive an FDA Inspection