Clinical Login Support Contact Sales
Products

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

Learn More

Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

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

View Product Tour

Accelerate development with integrated design control and risk software.

Learn More

Featured Capabilities:

Design Controls Risk Management Risk Intelligence

Schedule a custom demo of Greenlight Guru Product now.

REQUEST A DEMO

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

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

Get a personalized demo of Greenlight Guru Clinical today.

Request a Demo
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
Pricing
Request a Demo
Request a Demo

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.
featured
Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

View Post
Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
View Post
Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
View Post

Filter All Blog Posts

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.

Showing Results for

Product Development

State of Medical Device Product Development and Quality Management Report 2020

Jon Speer
November 25, 2019
Greenlight Guru, the only medical devicequality management system(MD QMS) software platform, today announced findings from the “State of Medical Device Product Development... Read More
Product Development

Best Practices for Expediting Your Product Development

Jon Speer
September 15, 2019
Speed to market is one of the major challenges for medical device companies. So, how can you expedite the process while maintaining quality and compliance? Read More
Establishing a QMS

5 Tips from MedTech Executives on the Value of Quality

Jon Speer
September 8, 2019
When it comes to making medical devices, quality is key. Read More
Product Development

Why the FDA Pre-Submission is an Underutilized Tool

Jon Speer
August 25, 2019
“I wish there was a way for the FDA to give me feedback about my medical device, prior to submission…” Read More
Establishing a QMS

6 Most Common Mistakes When Implementing ISO 13485

Jon Speer
July 21, 2019
Companies must establish and maintain a quality management system in order to ensure they are producing safe and effective medical devices. ISO 13485 specifies those... Read More
Post-Market Surveillance

How to Perform Effective Root Cause Analysis

Jon Speer
July 14, 2019
Picture this: something goes wrong with a medical device, and a complaint is issued. In a post-market situation, the medical device company responsible might get notified... Read More
Post-Market Surveillance

FDA QSIT: Preparing Your Medical Device Company for an Inspection

Jon Speer
June 17, 2019
Preparing for an FDA QSIT inspection can be a daunting task for medical device manufacturers. Many companies worry they will fail and often feel a sense of being “policed.” Read More
Establishing a QMS

5 Most Common Mistakes Made When Implementing ISO 14971

Jon Speer
June 2, 2019
ISO 14971 is a descriptive regulatory standard that provides guidance for how to apply risk management to medical devices. Read More
Establishing a QMS

The Essential Guide to Preparing your QMS for EU MDR

Jon Speer
May 27, 2019
How prepared is your quality management system for the new requirements of EU MDR for medical devices that will go into effect in less than a year? Read More

Experience the Guru Edge

Our industry expertise extends beyond our software. Explore our other resources that are helping leading MedTech companies reach success.

Academy

Accelerate your learning and proficiency - both in Greenlight Guru solutions and industry best practices. You’ll be equipped to build key competencies for your teams.

 Elevate Your Education
Community

You're not alone. We created a network of peers to connect with and learn from. At any stage of the product development lifecycle, become part of our community to accelerate your path to excellence.

 Find Your Community
Partner Ecosystem

We have over 200 strategic partnerships with leading consultants in quality, regulatory, testing, design, and clinical.

 Become a Partner
Resources

Do you have a unique problem that needs solving? Or maybe you’re just looking to elevate your expertise. If you're a MedTech professional looking to improve the quality of life for your patients, we have the right resources for you.

 Explore Our Content Hub