Greenlight Guru: Free Medical Device Webinars

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Ultimate Guide to Comparing Quality Management System Solutions

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Manufacturing of medical devices, design transfer and heading into the unknown

FDA disruption: mitigating risk in an unstable U.S. regulatory environment

Use related risk analysis & how it applies to medical device development

Lessons Learned: Avoiding Common Mistakes in ISO 13485 Certification

State of the Medical Device Industry in 2025

Cybersecurity and hidden threats in medical devices: real-world risks and the evolving regulatory landscape

Preclinical Testing Requirements for FDA Premarket Submissions

Expanding Horizons: Searching for the Ideal Early Feasibility Study (EFS) Location

Device Descriptions: The Most Poorly Written Part of Medical Device Submissions

New Year, New Rules - what to expect from EUMDR in 2025

Avoiding the Top Pitfalls in MedTech Clinical Data Collection: 2025 Strategies for Success

PMCF as Part of Lifecycle Management - Insights from Working with Notified Bodies

From Concept to Compliance: Aligning Stakeholders, User Needs, and Design Inputs

Predetermined Change Control Plans (PCCP): Approving medical device changes before you make them!

How much clinical data do you actually need: Have we overestimated the EU requirements?

The Importance of Integrating Regulatory Early into Product Development

Integrating Risk Management & CAPA: How to Supercharge Your Medical Device Quality

Clinical Submission Do's & Don’ts: Tips from a Former Notified Body Expert

How to Best Prepare for FDA QMSR

Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices

Preparing a Successful FDA Medical Device Submission

Greenlight Guru Clinical & BSI Life Sciences: Live Demo Integration

Maximizing Value from Design Controls: Strategies for Medical Device Companies

Integrating Clinical Strategy and Project Management for Cost-Effective Clinical Investigations

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