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Greenlight Guru Medical Device Blog

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How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
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...
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.
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 ...
Understanding Intended Use from ISO TR 24971:2020 - Featured Image

Understanding Intended Use from ISO TR 24971:2020

If you haven’t yet got into ISO TIR 24971:2020, there’s a fair bit to read up on.
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 ...
ISO 14971 Risk Management for Medical Devices: The Definitive Guide - Featured Image

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Examining the HHS Proposal for Premarket Notification Exemptions - Featured Image

Examining the HHS Proposal for Premarket Notification Exemptions

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS...
Recruiting Top Medical Device Talent in a Competitive Market - Featured Image

Recruiting Top Medical Device Talent in a Competitive Market

While robust growth in the medical device industry has seen more people coming into the field, it’s ...

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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