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Demystifying the De Novo Process - Featured Image

Demystifying the De Novo Process

By Nick Tippmann on May 12, 2022
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

By Nick Tippmann on May 6, 2022
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

By Nick Tippmann on May 4, 2022
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

By Nick Tippmann on April 29, 2022
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

By Nick Tippmann on April 27, 2022
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

By Nick Tippmann on April 20, 2022
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)

By Nick Tippmann on April 13, 2022
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

By Nick Tippmann on April 6, 2022
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

By Nick Tippmann on March 30, 2022
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

By Nick Tippmann on March 23, 2022
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

By Nick Tippmann on March 16, 2022
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

By Nick Tippmann on March 9, 2022
When developing a product in the medical device space, how does intellectual property (IP) protectio...

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