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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Post-Market Surveillance

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Post-Market Surveillance

5 Steps For Effective Trial Design and Improved Compliance

Jon Bergsteinsson
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

Etienne Nichols
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 31st. Read More
Product Development

CDRH Proposed Guidance for FY 2023

Etienne Nichols
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
Post-Market Surveillance

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

Jon Bergsteinsson
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

Jon Speer
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
Product Development

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

Etienne Nichols
December 14, 2022
EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are... Read More
Post-Market Surveillance

How to Use Greenlight Guru Clinical's ePRO Module

Páll Jóhannesson
December 9, 2022
Greenlight Guru Clinical is the only MedTech-specific electronic data capture (EDC) system. One of the first features built into our EDC system was an integrated e-mail and... Read More
Product Development

The Future of Healthcare & How We Get There

Etienne Nichols
December 7, 2022
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in... Read More
Post-Market Surveillance

How ePRO Can Help Comply with EU MDR Post-Market Surveillance

Jon Bergsteinsson
December 5, 2022
The EU MDR places more focus on Post-Market Surveillance (PMS) and clinical data collection. Since the EU MDR came into force, medical device manufacturers need to keep... Read More

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