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

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

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

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

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Posts by Jon Speer

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Jeff Perkins
September 18, 2023

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

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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

Etienne Nichols
May 11, 2023
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About the Author

Jon Speer is a medical device expert with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

Jon Speer
March 17, 2023
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Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

Jon Speer
February 16, 2023
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Product Development

Top Risk Management Tools in the Medical Device Industry

Jon Speer
February 3, 2023
The role of risk management for medical devices is not just a regulatory expectation, it’s a critical part of designing, developing, and manufacturing safe and effective... Read More
Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

Jon Speer
January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More
Product Development

Design Controls Need to Start With User Needs

Jon Speer
December 19, 2022
In the FDA’s classic design control waterfall diagram, the box at the left-hand top of the waterfall is labeled “user needs.” Read More
Establishing a QMS

How to Switch to eQMS Software When You're Just Using Paper

Jon Speer
December 5, 2022
How reliable is your paper-based quality management system? This situation plays out in medical device companies everywhere: Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

Jon Speer
December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

Jon Speer
November 15, 2022
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Establishing a QMS

What You Need to Know About Risk Management and Using Post-Market Data

Jon Speer
October 11, 2022
The aim for any medical device company is always to ensure that the devices they make are safe and effective. Read More

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