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

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Document Management Training Management CAPA Management Audit Management Product Development

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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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Greenlight Guru Medical Device Blog

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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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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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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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
MedTech Lifecycle Excellence

What NOT to say to FDA

Etienne Nichols
October 26, 2023
In this comprehensive episode, Etienne Nichols and Mike Drues dive into the enlightening world of FDA inspections. 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
MedTech Lifecycle Excellence

Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023

Jeff Perkins
October 24, 2023
The company continues to rapidly acquire large customers as its software continues to set the industry standard for quality and clinical MedTech solutions. 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
Establishing a QMS

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

Etienne Nichols
October 20, 2023
On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulation (QMSR). Read More

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