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4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information - Featured Image

Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information

We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our ...
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 ...
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps - Featured Image

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...
Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices - Featured Image

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...
5 Steps to Faster-to-Market, More Profitable Medical Devices - Featured Image

5 Steps to Faster-to-Market, More Profitable Medical Devices

Healthcare provider market demands are such that medical device companies often find themselves in s...
How to Structure your Medical Device Technical File - Featured Image

How to Structure your Medical Device Technical File

The medical device technical file is a must-have document for devices to be sold in the EU marketpla...
Pros & Cons of Being a Physician turned MedTech Inventor - Featured Image

Pros & Cons of Being a Physician turned MedTech Inventor

Do you fear needles and the associated pain? No one understands this fear more than physicians who s...
3 Systems of Risk for Medical Devices from FDA - Featured Image

3 Systems of Risk for Medical Devices from FDA

Why does FDA have three systems in place to address and handle risk for medical devices? Each system...
Am I Complying with FDA Medical Device Labeling Requirements? - Featured Image

Am I Complying with FDA Medical Device Labeling Requirements?

Medical device labeling requirements are a key part of getting your device to market.
How to Use the FDA ESG (Electronic Submissions Gateway) - Featured Image

How to Use the FDA ESG (Electronic Submissions Gateway)

The most competitive medical device companies embrace technology as a tool to make systems and proce...
Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients - Featured Image

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Why is design, manufacturing, quality, and culture so important in the medical device industry?

The Greenlight Guru Medical Device Blog

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