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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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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

Ultimate Guide to ISO 13485 for Medical Devices QMS

Jon Speer
October 2, 2023
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Regulatory Submission

Ultimate Guide to Device Class Requirements under EU MDR

Laura Court
September 19, 2023
Marketing a device in the European market means complying with the numerous safety and technical requirements of the Medical Device Regulation (MDR). In practice, this can be... Read More
Product Development

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

Jeff Perkins
September 18, 2023
Across the globe, visionaries and innovators are building the future of medical devices that improve the quality of life for millions of people. Read More
Product Development

How To Approach Supplier Corrective Action Requests (SCAR)

Taylor Brown
September 15, 2023
For medical device manufacturers, finding success means setting ourselves up for success with repeatable processes that not only ensure quality, but also mitigate future risk. Read More
Product Development

Engineering Change Order: Its Role in the Change Management Process

Jesseca Lyons
September 14, 2023
Change is just part of life for medical device companies. No device makes it to market without quite a few changes to its design along the way, and even devices already on... Read More
Product Development

5 Tips for Medical Device Registration across Global Markets

Etienne Nichols
September 14, 2023
You have compiled all of the necessary documentation for your regulatory submission, submitted it to the appropriate regulatory body, and received the much-anticipated news... Read More
Regulatory Submission

Accelerating SaMD Development in a Compliant Agile Way

Etienne Nichols
September 7, 2023
In this episode, we explore the impact of software development methodologies in the medical device industry. Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
September 1, 2023
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Regulatory Submission

MedTech Funding and Preparing for Due Diligence

Etienne Nichols
August 31, 2023
Join guest Devon Campbell as we discuss MedTech funding in this episode of the Global Medical Device Podcast. He unveils startup red flags, from data integrity to product... Read More

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