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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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MedTech Lifecycle Excellence

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

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
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
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
Product Development

5 Foundational Steps of a CAPA Quality Process

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Etienne Nichols
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

Tyler Foxworthy
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

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

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