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

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Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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

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Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Establishing a QMS

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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Jeff Perkins
September 18, 2023

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
May 11, 2023
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Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

Greenlight Guru
September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Product Development

Ultimate Guide to Device Class Requirements under EU MDR

Laura Court
September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Establishing a QMS

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

Etienne Nichols
September 13, 2023
The leaves may be starting to change, but one thing you can count on staying the same is G2 ranking Greenlight Guru as a Leader in both the QMS and Medical QMS Grid® Reports. Read More
Establishing a QMS

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

Etienne Nichols
September 1, 2023
In April 2023, FDA published a new draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning... Read More
Product Development

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

Etienne Nichols
August 25, 2023
Supply chain management is crucial to any MedTech company’s ability to deliver safe, effective, and high-quality devices to their customers. Read More
Product Development

Machine Learning, AI and Risk Management: TIR34971 Explained

Etienne Nichols
August 18, 2023
TIR34971:2023, Application of ISO 14971 to machine learning in artificial intelligence, was published in March 2023. Read More
Establishing a QMS

Conducting Quality Investigations in Medical Device Manufacturing

Etienne Nichols
August 11, 2023
When a quality event, like a product or process nonconformance, occurs in the manufacturing of medical devices, there’s a chance that the safety and efficacy of any affected... Read More
Establishing a QMS

Omnibus Act Impact on Medical Device Cybersecurity

Naomi Schwartz
August 7, 2023
The ‘‘Consolidated Appropriations Act, 2023’’ (H.R. 2617) was passed by the U.S. Senate and signed into law by President Biden on December 29, 2022. Read More
Establishing a QMS

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Etienne Nichols
July 21, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More

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