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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.
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
Clinical Data Collection

Ultimate Guide to Clinical Data Management in MedTech

Chris Rush
April 12, 2024
For many MedTech companies, especially those that manufacture high-risk devices, clinical trials are a crucial part of getting medical devices to market and keeping them... 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
Post-Market Surveillance

Improving Study Management in MedTech with Greenlight Guru Clinical’s Custom Collaborator Roles

Páll Jóhannesson
April 4, 2024
Greenlight Guru Clinical's recent introduction of Custom Collaborator Roles provides vital support to the MedTech clinical study arena. This feature brings a targeted... 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
Clinical Data Collection

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

Chris Rush
April 3, 2024
If there is one universal truth in MedTech clinical trials, it is that your study will take more time than you allot for it initially. Everyone, and I mean everyone,... 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

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