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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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Greenlight Guru Medical Device Blog

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

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

Etienne Nichols
October 17, 2023
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Regulatory Submission

EU MDR - 9 Top Questions Answered (European MDR)

Etienne Nichols
October 17, 2023
What is EU MDR? The European Medical Device Regulation (EU MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and... 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
Regulatory Submission

MHRA Guidance Document on Clinical Investigations in UK

Stephanie Hinton
October 10, 2023
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) is the agency that regulates medical devices and in vitro diagnostics, as well as clinical... 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
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

Jon Speer
October 2, 2023
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MedTech Lifecycle Excellence

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

Etienne Nichols
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

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