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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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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
September 1, 2023
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Establishing a QMS

The Ugly Truth About Managing Design Controls on Spreadsheets

Etienne Nichols
November 20, 2023
At one point in my career, after managing the design controls and risk management documentation, I decided to move on. Read More
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
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
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
Product Development

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Etienne Nichols
October 25, 2023
It was nothing more than a checklist that saved $175 million and 1,500 lives. Read More
Product Development

IQ, OQ, PQ: A Quick Guide to Process Validation

Jesseca Lyons
October 20, 2023
What is IQ, OQ, PQ? These are the abbreviations we use in the medical device industry for the three steps of process validation: Installation Qualification (IQ), Operational... Read More
Establishing a QMS

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

Laura Maher
October 20, 2023
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
October 19, 2023
I have a bold opinion: The corrective and preventive action (CAPA) process is the 2nd-most important component of your quality management system (QMS). Read More

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