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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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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
May 11, 2023
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Product Development

How to Improve Detecting, Correcting, and Preventing Nonconformances

Etienne Nichols
July 17, 2023
If you work at a MedTech company, nonconformances are a fact of life. As long as there is still a human element in the development and manufacture of medical devices, there... Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

Tom Rish
July 14, 2023
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Establishing a QMS

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Etienne Nichols
July 6, 2023
You know you need a new QMS solution. You may even have your sights set on an eQMS that you’ve evaluated and believe is the best option for your organization. Read More
Product Development

Identifying and Evaluating Medical Device Importers

Etienne Nichols
July 3, 2023
Expanding into new foreign markets is an exciting chapter for any medical device manufacturer. Read More
Product Development

How to Develop a Risk-Based Approach to Supplier Management

Etienne Nichols
June 18, 2023
The goal of your MedTech company’s supplier management process should be to ensure a consistent supply of high-quality parts and components that conform to your... Read More
Product Development

How to Manage Complex Downstream Design Changes to Your Medical Device

Etienne Nichols
June 11, 2023
It would be nice if every device your company ever produced got to remain on the market for decades, completely unchanged. Read More
Product Development

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Jesseca Lyons
June 4, 2023
In September of 2022, FDA issued a new draft guidance on software validation: Computer Software Assurance for Production and Quality System Software. Read More
Establishing a QMS

Making the Business Case for an eQMS Solution for Your Company

Jeff Perkins
June 2, 2023
As a MedTech Quality professional, you know that you need an eQMS solution. Working in a legacy or paper-based system can significantly impact your team’s overall speed and... Read More
Product Development

Managing Major Changes to Medical Device Packaging

Etienne Nichols
May 29, 2023
Charles Darwin famously said, “It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is most adaptable to change.”... Read More

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