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Greenlight Guru Medical Device Blog

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7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
How to Build Medical Device Usability Testing and Validation into Your Quality System - Featured Image

How to Build Medical Device Usability Testing and Validation into Your Quality System

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...
Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community - Featured Image

Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

Greenlight Guru Academy will educate and train medical device professionals on everything they need ...
5 Actionable Lessons Learned from the RADx Initiative by NIH - Featured Image

5 Actionable Lessons Learned from the RADx Initiative by NIH

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...
Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster - Featured Image

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

Customers benefit from expert advice to lower development costs and save time identifying the right ...
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA - Featured Image

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...
What Goes into Designing Devices for Military and Emergency Applications? - Featured Image

What Goes into Designing Devices for Military and Emergency Applications?

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...
Medical Device Biocompatibility 101 - Featured Image

Medical Device Biocompatibility 101

Medical device biocompatibility can be confusing, challenging, even frustrating for device professio...
Why Biocompatibility Should be Addressed by Every Medical Device Company - Featured Image

Why Biocompatibility Should be Addressed by Every Medical Device Company

Should your medical device company address biocompatibility? The short answer is, yes. Every single ...
How to Write a Nonconformance Report - Featured Image

How to Write a Nonconformance Report

Nonconformance is a word no quality manager wants to hear.
Quality Assurance vs. Quality Control in the Medical Device Industry - Featured Image

Quality Assurance vs. Quality Control in the Medical Device Industry

Imagine that your medical device malfunctioned during patient use. Do you know whether quality assur...
Addressing Clinical Trial Challenges & Concerns during COVID-19 - Featured Image

Addressing Clinical Trial Challenges & Concerns during COVID-19

The current COVID-19 pandemic and its impact on clinical trials has created a sense of chaos amongst...

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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