Greenlight Guru: Podcast

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Ultimate Guide to Comparing Quality Management System Solutions

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The Danger of In-Home Use Medical Devices, Pt. 2

The Danger of In-Home Use Medical Devices, Pt. 2

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

The Trouble with Home-Use Devices, Pt. 1

Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

What Standards Apply to My Device?

Design of Experiments - How and When to Use DOE

MedTech Advice from an Accidental Entrepreneur

Navigating the Complex World of Combination Products

Meet the Guru: Building Quality Management in Early-Stage Medical Device Companies

Who Owns the Design Controls Process?

Designing a Medical Device for a Global User

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Clinical Evidence: The Key to Market Adoption

Creative Clinical Recruitment

Getting Hired In MedTech

Achieving ISO 13485 Certification

Meet a Guru: Jamie Bihary

Advice to Medical Device Inventors

Obtaining Institutional Review Board (IRB) Approval

Interviewing the Interviewer

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

Medical Device Reporting: The Do's and Don'ts

Building a Partnership with your Regulatory Consultant

Bringing a Self-Funded Medical Device to Market

Managing Risk in Clinical Investigations

Speaking the Language of IVD

Is It Possible to "Buy" a QMS?

Project Management in MedTech

FDA's Voluntary Improvement Program

The State of UDI Across the World

Quality Myths & Lessons Learned Part II

Mastering the Pitch: MedTech Innovations from Concept to Market

Becoming a MedTech Regulatory Affairs Professional

How Artificial Intelligence is Impacting the MedTech Industry

Fundamentals of Quality & Regulatory

The State of AI & Clinical Investigations

The Evolving Landscape of AI in MedTech

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

Considerations for IVD

Human-Centered Design in Medical Devices

FDA's eSTAR Program

Using AI in MedTech

Becoming an Advisor to a Medical Device Company

Recent FDA Draft Guidances

Planning an FDA Submission

What NOT to say to FDA

Understanding LDTs & the FDA Proposed Ruling

UDI and EUDAMED: Past, Present and Future State

Selecting a Site for Your Clinical Trial

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

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

Accelerating SaMD Development in a Compliant Agile Way

MedTech Funding and Preparing for Due Diligence

Exploring Breakthrough Device Designation

Regulatory Strategy and the Advantage of Diversity in MedTech

28 Days To Save The World - True Quality Roadshow

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

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

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

The Role of dFMEA in Risk Management for Medical Devices

Understanding the ROI of an eQMS

CSA vs. CSV: Modern Validation for Modern MedTech

Management Responsibility: The most important part of a QMS

The Combination Products Handbook

Leaning into Lean Documentation

Cybersecurity and the Future of MedTech

Ad Promo and The Difference in Regulatory & Legal

How AI Can Help You Manage Risk

The Tools that Make Clinical Investigations

Complaint Handling with Medical Device Guru, Brittney McIver

Avoiding Potential Issues with your 510(k) Submission

Meet a Guru: Brittani Smith

Why Building Supplier Relationships Is So Important

Systematic Literature Review for EU MDR