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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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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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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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Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

Tom Rish
April 14, 2023
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More
Establishing a QMS

2023 Greenlight Guru True Quality Roadshow: Houston Recap

Greenlight Guru
April 12, 2023
Thank you, Houston! The 2023 True Quality Roadshow got off to an exciting start on March 9th, as Greenlight Guru, along with sponsors Velentium and Rook Quality Systems,... Read More
Product Development

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

Etienne Nichols
April 9, 2023
Risk management is a notoriously complex subject—one that many people (including yours truly) have strong feelings about. Read More
Establishing a QMS

“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report

Etienne Nichols
April 6, 2023
Greenlight Guru is honored to announce that it has been selected - by users - as the leading QMS for the eighteenth consecutive quarter in G2’s Spring 2023 QMS Grid Report. Read More
Product Development

eBOM vs mBOM: What’s the Difference?

Niki Price
March 31, 2023
A bill of materials (BOM) contains all the materials and parts required to build your device, as well as directions for how to use them and where to acquire them. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

Etienne Nichols
March 31, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies. Read More
Product Development

How to Handle Medical Device Adverse Events

Etienne Nichols
March 24, 2023
Medical device adverse events can be a daunting challenge for any manufacturer to address. Read More
Product Development

Making the BOM & Design Controls Connection

Niki Price
March 19, 2023
Your bill of materials (BOM) is a comprehensive list of all the materials and parts required to build your device, as well as directions for how to use them and where to... Read More
Establishing a QMS

Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions

Etienne Nichols
March 17, 2023
One of the most critical decisions a MedTech company will make is choosing the right quality management system (QMS) solution. The QMS solution you choose will have a... Read More

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