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

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Featured Capabilities:

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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MedTech Lifecycle Excellence

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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featured

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
September 1, 2023
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Establishing a QMS

Enterprise Quality Management Software: What You Need To Know

Etienne Nichols
November 14, 2023
A quality management system (QMS) is simply a formalized system for documents, policies, procedures, and processes that companies in many industries—including MedTech—use to... Read More
Regulatory Submission

Recent FDA Draft Guidances

Etienne Nichols
November 9, 2023
In this episode, we dissect the evolving landscape of FDA medical device regulations with regulatory expert Mike Drues. Read More
MedTech Lifecycle Excellence

The AI in MedTech Trend Report 2023 Is Here

Jeff Perkins
November 7, 2023
At Greenlight Guru, when we want to know exactly what’s happening in the MedTech industry, we like to go to the source: the medical device professionals who work every day to... Read More
MedTech Lifecycle Excellence

Greenlight Guru Releases The AI in MedTech Trend Report 2023

Greenlight Guru
November 7, 2023
The survey of more than 200 medical device professionals is a snapshot into the interest and attitudes toward AI tools and their adoption in the MedTech industry. Read More
Regulatory Submission

Planning an FDA Submission

Etienne Nichols
November 2, 2023
In this episode, Etienne Nichols and Ellie Reynolds, Associate Director of Quality Assurance and Regulatory Affairs at Proxima Clinical Research, dive deep into the... Read More
Establishing a QMS

Benefits of Switching from MasterControl to Greenlight Guru

Etienne Nichols
November 2, 2023
At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech... Read More
MedTech Lifecycle Excellence

Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who

Delve
November 1, 2023
Industry research shows that each year, approximately 400,000 hospitalized patients experience some kind of preventable harm. Read More
Product Development

Ultimate Guide to Software as a Medical Device (SaMD)

Wade Schroeder
October 30, 2023
Only recently has the medical device industry began designing software-based products that have no direct relationship to hardware devices at all. Read More
Establishing a QMS

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

Etienne Nichols
October 27, 2023
The FDA’s Quality System Regulation (QSR) and ISO 13485:2016 both lay out requirements for a medical device manufacturer’s QMS. (The two will soon be harmonized, but that’s... Read More

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

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Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

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