Blog
Startup Program
Partner Program
Call us: 317-960-4220
Email
Search
Software Tour
Overview
Design Control
Risk Management
Document Management
All Features
Events & Resources
Webinars, Ebooks & Guides
Podcast
Thought Leadership Articles
Newsletter
Our Customers
Testimonials
Case Studies
Services
Overview
Service Packages
Launch Packages
Support
greenlight.guru Guest Thought Leadership Articles
Our best medical device content published on other industry leading publications
Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'
Medical Device and Diagnostic Industry
April 25th, 2017
4 key compliance issues for medical device companies
MedCity News
April 13th, 2017
Five Tips for Medical Device Engineers on FDA Design Controls
Quality Digest
by Jon Speer on March 28th, 2017
5 predictions for the medical device industry
MedCity News
by Jon Speer on March 3rd, 2017
Key Challenges for Risk Management in Medical Device Development
Quality Digest
by Jon Speer on February 13th, 2017
3 tips for managing your medical device design history file
MedCity News
by Jon Speer on October 16th, 2016
4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)
Med Device Online
by Jesseca Lyons on September 19th, 2016
3 Tips to Reduce the Chance of a 510(k) Submission Rejection
Medical Product Outsourcing
by Jesseca Lyons on September 15th, 2016
Six Tips to Make Sure Your 510(k) Submission Is Accepted
Quality Digest
by Jon Speer on August 23rd, 2016
6 tips to reduce likelihood of a rejection for an FDA 510(k) submission
MedCity News
by Jon Speer on August 18th, 2016
4 Tips for a Smooth 510(k) Submission Process
Medical Device and Diagnostics Industry
by Jon Speer on August 17th, 2016
ISO 14971 or FMEA: Which Should You Use?
Quality Digest
by Jesseca Lyons on August 9th, 2016
First-In-Human Studies - What's The Rush?
Med Device Online
by Jon Speer on July 27th, 2016
Debunking 4 commonly held design control myths
MedCity News
by Jon Speer on July 25th, 2016
Navigating the difficult road of medical device product development while avoiding the common pitfalls
MedCity News
by Jon Speer on July 14th, 2016
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
Quality Digest
by Jon Speer on July 5th, 2016
Understanding ISO 14971 medical device risk management
MedCity News
by Jon Speer on June 6th, 2016
3 tips for applying risk management across medical device product development
MedCity News
by Jon Speer on May 26th, 2016
The Definitive Guide to Responding to FDA 483 and Warning Letters
Medical Design Technology
by Jon Speer on May 19th, 2016
What were the top reasons FDA issued device makers 483’s and warning letters in 2015
MedCity News
by Jon Speer on May 19th, 2016
8 Reasons Design Controls And Risk Management Processes Fail
Med Device Online
by Jon Speer on May 19th, 2016
How design controls apply to a 510(k)
MedCity News
by Jon Speer on May 5th, 2016
Get and stay on the FDA's good side with Jon Speer
Inspired by Imua Podcast
April 21st, 2016
Why FMEA Is Not ISO 14971
Quality Digest
by Jon Speer on April 20th, 2016
Are Design Control Myths Holding Back Your Product Development?
Med Device Online
by Jon Speer on April 1st, 2016
A Step-by-Step Guide to Complying with Medical Device QMS Requirements
Medical Design Technology
by Jon Speer on March 9th, 2016
MedTech Blunders in Risk Management
MedTech Intelligence
by Jon Speer on March 4th, 2016
5 Tips to Help Your FDA 510(k) Submission (checklist included)
MedCity News
by Jon Speer on March 1st, 2016
Risk: Look at the Big Picture
MedTech Intelligence
by Jon Speer on February 15th, 2016
How to Prepare for an FDA Inspection
Quality Digest
by Jon Speer on February 8th, 2016
6 Development Steps To Fast-Track Your Medical Device's Path To Market
Med Device Online
by Jon Speer on February 5th, 2016
The Design Controls + Risk Management Connection — Using Design Reviews Effectively
Med Device Online
by Jon Speer on January 10th, 2016
An alarming device trend: Why getting 510(k) clearance alone is not enough
MedCity News
by Jon Speer on December 16th, 2015
7 Steps to Respond to FDA 483 Inspection Observations
MedTech Intelligence
by Jon Speer on November 12th, 2015
The Design Controls + Risk Management Connection — Verification, Validation & Risk Controls
Med Device Online
by Jon Speer on November 16th, 2015
The Importance of the Risk Management Plan
Medical Design Technology
by Jon Speer on November 10th, 2015
Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]
MedCity News
by Jon Speer on November 9th, 2015
Risk Management: A Total Product Life-cycle Process [Infographic]
Legacy MEDSearch
by Jon Speer on November 6th, 2015
Risk Management for Medical Devices: An Introduction to the Process [Infographic]
Qmed
by Jon Speer on November 5th, 2015
Risk management definitions you need to understand
Mass Device
by Jon Speer on November 5th, 2015
The beginner’s guide to MedTech design verification and validation
MedCity News
by Jon Speer on October 30th, 2015
How to Avoid Exponentially Escalating Costs with Design Controls
Qmed
by Jon Speer on October 28th, 2015
3 Tips for Incorporating Risk Management Throughout Medical Device Product Development
Medical Design Technology
by Jon Speer on October 20th, 2015
The Design Controls + Risk Management Connection — Intended Use & User Needs
Med Device Online
by Jon Speer on October 19th, 2015
5 tips to help you prepare for an FDA inspection
MedCity News
by Jon Speer on October 13th, 2015
4 Reasons Your Risk Management Approach is Wrong
MedTech Intelligence
by Jon Speer on September 28th, 2015
How to make FDA work for you – ATL Device Night
Mass Device
by Nick Tippmann on September 25th, 2015
The $400,000 FDA compliance mistake you don’t want to make
MedCity News
by Jon Speer on September 23rd, 2015
5 Tips For Better Medical Device Risk Management
Med Device Online
by Jon Speer on September 15th, 2015
How to define medical device design inputs and outputs
MedCity News
by Jon Speer on September 15th, 2015
The Beginner's Guide to ISO 14971 Medical Device Risk Management
Medical Design Technology
by Jon Speer on September 15th, 2015
How medical device complaints can make you a better company
MedCity News
by Jon Speer on September 10th, 2015
Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA
OrthoStreams
by Jon Speer on September 3rd, 2015
How to improve your medical device startup’s funding chances
MedCity News
by Jon Speer on September 1st, 2015
Stop Treating Risk Management & Design Controls As Checkbox Activities
Med Device Online
by Jon Speer on September 1st, 2015
Three ways to determine whether your medical device company suffers from disconnect
MedCity News
by Jon Speer on August 19th, 2015
Is your risk management system for medical devices up to date?
MedCity News
by Jon Speer on August 12th, 2015
What’s the best approach to medical device Design Reviews?
MedCity News
by Jon Speer on August 5th, 2015
Are We in the Golden Age of Medical Devices?
Medical Design Technology
by Jon Speer on July 29th, 2015
5 Tips To Help Your FDA 510(k) Submission (Checklist Included)
Med Device Online
by Jon Speer on July 16th, 2015
Top Three Document Management Tips for Medical Device Companies
Quality Digest
by Jon Speer & Alex Morris on July 8th, 2015
3 steps to getting your medical device startup off the ground
MedCity News
by Jon Speer on July 1st, 2015
Regulatory classification 101: A guide to how your medical device will be classified
MedCity News
by Jon Speer on June 22nd, 2015
What issues draw the most attention in FDA medical device inspections?
MedCity News
by Jon Speer on June 8th, 2015
The Medtech Adventures of Eddy the Engineer
Qmed
by Jon Speer on June 2nd, 2015
15 items medical device startups need to address
MedCity News
by Jon Speer on May 27th, 2015
Why medical device startups need to master juggling and balancing with focus
MedCity News
by Jon Speer on May 13th, 2015
4 medical device quality system musts for startups
MedCity News
by Jon Speer on April 30th, 2015
The Art Of Medical Device Design Inputs
Med Device Online
by Jon Speer on April 27th, 2015
Eight Questions That Define Your Medical Device User Needs
Quality Digest
by Jon Speer on April 21st, 2015
2 things you should do asap when starting a medical device project
MedCity News
by Jon Speer on April 16th, 2015
Your 5 Step Blueprint for Great MedTech Design Reviews
Qmed
by Jon Speer on April 9th, 2015
How to run effective medical device design reviews
MedCity News
by Jon Speer on April 9th, 2015
3 Tips for Managing Your Medical Device Design History File
Medical Design Technology
by Jon Speer on March 31st, 2015
From Idea to Market Release: Your Quick Guide to FDA Design Controls
MedCity News
by Jon Speer on March 30th, 2015
How Medtech Startups Can Navigate Design Controls
Qmed
by Jon Speer on March 12th, 2015
"Finally, QMS software that's both
compliant
and
practical
to use"
HELPING SOME OF THE WORLD'S MOST INNOVATIVE MEDICAL DEVICE COMPANIES BRING SAFER PRODUCTS TO MARKET FASTER
