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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Document Management Training Management CAPA Management Audit Management Product Development

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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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Featured Capabilities:

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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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
On January 31st, 2024, FDA issued their final rule amending the Quality System Regulation (QSR) to better align with ISO 13485:2016, the international standard for quality... Read More
MedTech Lifecycle Excellence

Calculating Nonconformance Costs in the MedTech Industry

Etienne Nichols
February 2, 2024
In the MedTech industry, nonconformance costs are about more than just your company’s bottom line. Read More
MedTech Lifecycle Excellence

Introducing Risk Reviews for Efficient, Compliant Risk Management

Tory Lopez
February 2, 2024
This week at Greenlight Guru, we released several new updates to Greenlight Guru Quality, including Risk Reviews, the latest addition to our new Risk Management workspace. Read More
MedTech Lifecycle Excellence

How Artificial Intelligence is Impacting the MedTech Industry

Etienne Nichols
January 30, 2024
In this episode, Etienne Nichols and guest Ashkon Rasooli explore the transformative impact of AI in the medical device industry. From AI-driven diagnostics and wearable... Read More
MedTech Lifecycle Excellence

Greenlight Guru Finishes 2023 with Strong Momentum in Q4

Jeff Perkins
January 24, 2024
The company continues to acquire large customers and gain accolades for its quality and clinical MedTech solutions. Read More
MedTech Lifecycle Excellence

IVDR: How to Meet the Quality Management System Requirements of a Device

Enrico Perfler
January 18, 2024
When we talk about a Quality Management System (QMS), we refer to the set of all processes related to the creation of a product/service, from planning, design, and... Read More
MedTech Lifecycle Excellence

Fundamentals of Quality & Regulatory

Etienne Nichols
January 18, 2024
In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Read More
MedTech Lifecycle Excellence

The State of AI & Clinical Investigations

Etienne Nichols
January 11, 2024
In a today's conversation on the Global Medical Device Podcast, host Etienne Nichols engages with Dr. Maria Nyakern on the burgeoning integration of AI in medical devices. Read More
MedTech Lifecycle Excellence

How PLM and QMS Solutions Work Together in MedTech

Tory Lopez
January 10, 2024
A quality management system (QMS) and a product lifecycle management (PLM) system are closely related parts of the tech stack at many modern MedTech companies. Read More

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