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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.

Establishing a QMS

Four Years, For You

Nick Tippmann
September 27, 2022
Celebrating Four Years as the Leading QMS, as Selected by Users Read More
Product Development

UDI and the Current State of Global Implementation

Nick Tippmann
August 17, 2022
What is the current state of unique device identification (UDI) in the United States versus the European Union (EU)? What are the current deadlines, complexities, and... Read More
Product Development

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Nick Tippmann
August 10, 2022
How is the changing job market affecting careers for professionals in MedTech? How can video storytelling strategies and techniques impact talent access? Read More
Product Development

Digitizing your SaMD Testing

Nick Tippmann
August 3, 2022
What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Nick Tippmann
July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  Read More
Establishing a QMS

Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications

Nick Tippmann
July 21, 2022
The certifications for a Quality Management System and an Information Security Management System provide third-party validation of Greenlight Guru’s operating system and... Read More
Product Development

Guerilla Tactics for Quality Leadership

Nick Tippmann
July 20, 2022
What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required -... Read More
Product Development

Preventing the Death of Medical Device Sales

Nick Tippmann
July 13, 2022
The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and... Read More
Product Development

Shifting Sands of SaMD Cybersecurity Regulations

Nick Tippmann
July 5, 2022
FDA has issued new draft guidance on cybersecurity for software as a medical device (SaMD). If the FDA releases that draft guidance ‘as is,’ it will massively and negatively... Read More

Experience the Guru Edge

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