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Establishing a QMS

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

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

5 Foundational Steps of a CAPA Quality Process

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
Establishing a QMS

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

October 17, 2023
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Product Development

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

October 13, 2023
On October 3, 2023, the Food and Drug Administration (FDA) published a proposed rule seeking to amend FDA’s regulations to bring Laboratory Developed Tests (LDTs) under the... Read More
Product Development

Guide to Understanding AI Applications that Drive Business Value in MedTech

October 6, 2023
Greenlight Guru recently surveyed more than 200 MedTech professionals to find out whether they were using AI in their work and what they thought about its potential to help... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 2, 2023
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Establishing a QMS

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

September 19, 2023
The software company is expanding its product offering to meet the evolving needs of the medical device industry. Read More
Product Development

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

September 18, 2023
Across the globe, visionaries and innovators are building the future of medical devices that improve the quality of life for millions of people. Read More
Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More

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