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Demystifying the De Novo Process - Featured Image

Demystifying the De Novo Process

How do you navigate the De Novo process for your medical device? When do you decide to go that route...
Challenges for Regulatory Submission: EU vs. US - Featured Image

Challenges for Regulatory Submission: EU vs. US

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing w...
From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE - Featured Image

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezer...
The Future of Cybersecurity - Featured Image

The Future of Cybersecurity

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers nee...
Achieving Operational Readiness through Good Project Management - Featured Image

Achieving Operational Readiness through Good Project Management

In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Patrick Hayes, Associ...
Bridging the Gap between Medical Devices and Clinical Data - Featured Image

Bridging the Gap between Medical Devices and Clinical Data

Selling a medical device in the EU? Understanding the importance of clinical data and what's require...
Navigating the Medical Device Single Audit Program (MDSAP) - Featured Image

Navigating the Medical Device Single Audit Program (MDSAP)

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory require...
Bringing Augmented Reality MedTech to Market - Featured Image

Bringing Augmented Reality MedTech to Market

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablat...
Making Your Informational Meetings with FDA Valuable & Worthwhile - Featured Image

Making Your Informational Meetings with FDA Valuable & Worthwhile

What are informational meetings with the FDA, why should you schedule them, and how should they be c...
Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs - Featured Image

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. W...
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices - Featured Image

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...
How Medical Device Intellectual Property Protection Varies by Sector - Featured Image

How Medical Device Intellectual Property Protection Varies by Sector

When developing a product in the medical device space, how does intellectual property (IP) protectio...

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