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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
MedTech Lifecycle Excellence

Understanding LDTs & the FDA Proposed Ruling

October 19, 2023
In this episode, host Etienne Nichols and Shannon Bennett, a regulatory affairs expert in the diagnostic testing space dive into the FDA's proposed rules for Laboratory... Read More
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
MedTech Lifecycle Excellence

UDI and EUDAMED: Past, Present and Future State

October 12, 2023
In this episode, we discuss the past, present, and future state of EUDAMED. EUDAMED is the European Database for Medical Devices, and is part of the European Medical Device... 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
MedTech Lifecycle Excellence

Selecting a Site for Your Clinical Trial

October 5, 2023
In this episode, we discuss how to select a site for a clinical trial. Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 2, 2023
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MedTech Lifecycle Excellence

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

September 21, 2023
In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD)... Read More
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

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