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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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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

FDA’s PMA Supplements and Amendments: When and How to Use Each

Etienne Nichols
April 19, 2024
The regulatory pathway for getting a Class III medical device to market in the US is known as Premarket Approval (PMA). Given that Class III devices pose the highest risk to... Read More
MedTech Lifecycle Excellence

Is It Possible to "Buy" a QMS?

Etienne Nichols
April 12, 2024
In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry. Read More
MedTech Lifecycle Excellence

What is a Class III Medical Device in the US?

Etienne Nichols
April 8, 2024
In the US, the Food and Drug Administration (FDA) is the federal agency tasked with regulating the medical device market and ensuring the safety and effectiveness of all... Read More
MedTech Lifecycle Excellence

Project Management in MedTech

Etienne Nichols
April 4, 2024
This episode of the Global Medical Device Podcast features a compelling conversation with Perry Parendo, a seasoned expert in product development and project management... Read More
MedTech Lifecycle Excellence

Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories

Tory Lopez
April 4, 2024
This recognition underlines Greenlight Guru's commitment to innovation and customer-centric service in the MedTech industry. Read More
Regulatory Submission

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

Etienne Nichols
April 2, 2024
The premarket approval (PMA) process is the method FDA uses to evaluate the safety and effectiveness of Class III medical devices before they can be placed on the US market. Read More
MedTech Lifecycle Excellence

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

Sara Adams
March 27, 2024
In Greenlight Guru’s 2024 State of the MedTech Industry Report, respondents cited a number of common challenges related to training management, including: Read More
MedTech Lifecycle Excellence

FDA's Voluntary Improvement Program

Etienne Nichols
March 21, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss... Read More
MedTech Lifecycle Excellence

The State of UDI Across the World

Etienne Nichols
March 7, 2024
In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and... Read More

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