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Greenlight Guru QMS

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

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Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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SMART-TRIAL by
Greenlight Guru

Data gathering and management designed for MedTech clinical trials and operations.

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Featured Capabilities:

Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

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Greenlight Guru Academy

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

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Posts by Nick Tippmann

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Product Development
Etienne Nichols
May 11, 2023

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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Establishing a QMS

Ultimate Guide to Postmarket Surveillance of Medical Devices

Brittani Smith
February 26, 2023
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Post-Market Surveillance

Selecting The Ideal PMCF Activity

Jon Bergsteinsson
July 17, 2022
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About the Author

Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later acquired.

Product Development

The Future of Cybersecurity

Nick Tippmann
April 29, 2022
What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices... Read More
Product Development

Achieving Operational Readiness through Good Project Management

Nick Tippmann
April 27, 2022
In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning... Read More
Product Development

Bridging the Gap between Medical Devices and Clinical Data

Nick Tippmann
April 20, 2022
Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.  Read More
Product Development

Navigating the Medical Device Single Audit Program (MDSAP)

Nick Tippmann
April 13, 2022
Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will... Read More
Product Development

Bringing Augmented Reality MedTech to Market

Nick Tippmann
April 6, 2022
Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old. Read More
Product Development

Making Your Informational Meetings with FDA Valuable & Worthwhile

Nick Tippmann
March 30, 2022
What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early... Read More
Establishing a QMS

Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies

Nick Tippmann
March 24, 2022
Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for the fourteenth consecutive quarter in G2’s Spring 2022 QMS Grid Report. Read More
Product Development

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Nick Tippmann
March 23, 2022
For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used... Read More
Establishing a QMS

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Nick Tippmann
March 16, 2022
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems.... Read More

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