Greenlight Guru: Resource Hub

Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

Subscribe to our Resource Hub

Be the first to know the latest news in the MedTech industry.

Join 200,00+ other medical device professionals outperforming their peers.

Focus on the Work That Matters Most.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

Please insert a valid email address

Featured Capabilities:

Featured Capabilities:

Ultimate Guide to Comparing Quality Management System Solutions

Resource Hub

No results

Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends

Medical Device Product Development Case Study

Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

CAPA Process Mistakes You Want to Avoid

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 15X in SIX Years

What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?

How Sonavex Went from Concept to FDA Clearance in Just 3 Years

Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

Advancing MRI Technology As We Know It Today

Improving the Colon Cancer Screening Experience

Creating a Culture of Quality for Medical Device Companies

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

Implementing Changes to SaMD under New EU MDR

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

How to Leverage IEC 62304 to improve SaMD Development Processes

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting A Data-driven Approach With their Quality System

Meet a Guru: Erica Loring

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

What are the Strategic Priorities for CDRH in 2021?

Case Study: How Delta Development Fast-tracked R&D Down to 1 Year by Implementing a Medical Device QMS

Everything you Need to Know about SaMD from an FDA Perspective

Meet a Guru: Karen Schuyler

Case Study: How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Centese Trades in Paper-based QMS for Greenlight Guru Quality & Achieves 510(k) Clearance

Meet a Guru: Ryan Behringer

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

Approaching Cybersecurity & Usability as a SaMD Company

Shifting Sands of SaMD Cybersecurity Regulations

Digitizing your SaMD Testing

Common QMS Mistakes SaMD Companies Make

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

The Best of Jon & Mike Through the Years

Ad Promo and The Difference in Regulatory & Legal

Cybersecurity and the Future of MedTech

Leaning into Lean Documentation

The Combination Products Handbook

Management Responsibility: The most important part of a QMS

CSA vs. CSV: Modern Validation for Modern MedTech

Understanding the ROI of an eQMS

The Role of dFMEA in Risk Management for Medical Devices

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

The Right Way to Start a QMS: When, How, & What

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

28 Days To Save The World - True Quality Roadshow

Regulatory Strategy and the Advantage of Diversity in MedTech

Exploring Breakthrough Device Designation

MedTech Funding and Preparing for Due Diligence

Accelerating SaMD Development in a Compliant Agile Way

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Selecting a Site for Your Clinical Trial

UDI and EUDAMED: Past, Present and Future State

Understanding LDTs & the FDA Proposed Ruling

What NOT to say to FDA

Planning an FDA Submission

Recent FDA Draft Guidances

Becoming an Advisor to a Medical Device Company

Using AI in MedTech

FDA's eSTAR Program

Human-Centered Design in Medical Devices

Considerations for IVD

Climbing the MedTech Career Ladder - How to Get to the Top

The Evolving Landscape of AI in MedTech

The State of AI & Clinical Investigations