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Product Development

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained

January 1, 2023
In both the US and the EU, medical devices may be required to undergo a clinical trial before they can be placed on the market. A clinical trial is a systematic assessment of... Read More
Product Development

5 Steps For Effective Trial Design and Improved Compliance

December 29, 2022
This blog post will address a number of elements which are important for overcoming some of the challenges faced in clinical trials – whether it’s pharmaceutical, medical... Read More
Product Development

The Best of Jon & Mike Through the Years

December 28, 2022
Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31... Read More
Product Development

Most Popular Medical Device Content in 2022

December 25, 2022
“One heartbeat led us here.” Throughout 2022, this has been our signature rallying cry. Sure, it’s got a nice ring to it, and it doesn’t look too bad on a t-shirt either. But... Read More
Product Development

Optimizing Generation of Clinical Evidence for Medical Devices

December 22, 2022
MEDDEV 2.7/1 revision 4, defines clinical evidence as:"The clinical data and the clinical evaluation report pertaining to a medical device." This is both a simple and valid... Read More
Product Development

CDRH Proposed Guidance for FY 2023

December 21, 2022
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them?  Read More
Establishing a QMS

A Year of Scale, Support, and Celebration

December 20, 2022
Greenlight Guru ranks as the #1 QMS and Medical QMS in 2022 Read More
Product Development

Randomization in Medical Device Clinical Trials: Everything You Need to Know

December 20, 2022
The purpose of MedTech clinical investigations is to gain insights about the safety and effectiveness of a medical device. To ensure the quality of those insights, clinical... Read More
Product Development

Design Controls Need to Start With User Needs

December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More

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