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3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.
Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification - Featured Image

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

In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13...
Understanding the Premarket Approval (PMA) Process - Featured Image

Understanding the Premarket Approval (PMA) Process

Before any medical device can hit the US market, FDA must first evaluate the product’s potential ris...
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

One of the most important steps in bringing a medical device to market in the European Union (EU) is...
Understanding the FDA Medical Device Classification System - Featured Image

Understanding the FDA Medical Device Classification System

The world of medical devices is one of the most varied and complex industries around today. Innovati...
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards - Featured Image

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

As more and more medical devices utilizing network connection technology are developed, cybersecurit...
Applying ISO 10993-1 to Medical Device Submission to FDA - Featured Image

Applying ISO 10993-1 to Medical Device Submission to FDA

ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation ...
Explaining the Role of Importer under EU MDR - Featured Image

Explaining the Role of Importer under EU MDR

What is the role of the importer, according to EU MDR? The requirements for this role have changed s...
Does My Device Labeling Comply with 21 CFR 801? - Featured Image

Does My Device Labeling Comply with 21 CFR 801?

Medical device labeling is a core requirement for getting your device onto the market.
Preparing Your Pre-Submission with the Content FDA Wants to See - Featured Image

Preparing Your Pre-Submission with the Content FDA Wants to See

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can us...
How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021 - Featured Image

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomed...
How New Training Partnership is Advancing Medical Device Knowledge & Professional Development - Featured Image

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device ...

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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