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FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You? - Featured Image

FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

By Nick Tippmann on July 18, 2018
The FDA announced a new proposal regarding the bundling of device malfunctions when Medical Device R...
Why is Document Control Important for Medical Device Companies? - Featured Image

Why is Document Control Important for Medical Device Companies?

By Jon Speer on July 17, 2018
If you're a medical device company, the entire goal of your organization is to produce a medical dev...
A Guide to Bridging User Needs Into Design Requirements - Featured Image

A Guide to Bridging User Needs Into Design Requirements

By Jon Speer on July 16, 2018
  “The answers are only as good as the questions we ask!”
Why There is a Need for Multi-Level Design Controls - Featured Image

Why There is a Need for Multi-Level Design Controls

By Nick Tippmann on July 12, 2018
We’ve added an exciting new update to our platform recently. The ability to manage multi-level desig...
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage - Featured Image

How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

By Nick Tippmann on July 12, 2018
Do you know how to use the FDA’s abbreviated 510(k)? Since only 2 percent of 510(k)s have gone the a...
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years - Featured Image

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years

By Connor Remaley on July 10, 2018
  Have you ever wondered what partnering with Greenlight Guru could mean for your business? We have ...
7 Questions About the European MDR Answered - Featured Image

7 Questions About the European MDR Answered

By Jon Speer on July 2, 2018
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production...
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors! - Featured Image

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

By Mary Beth Privitera, PhD, FIDSA on June 18, 2018
If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
What Medical Device Developers Should Know About Human Factors - Featured Image

What Medical Device Developers Should Know About Human Factors

By Jon Speer on June 11, 2018
  Human factors can be a topic rife with confusion for medical device developers. What do they mean?...
Tips for Running Effective Internal Quality Audits - Featured Image

Tips for Running Effective Internal Quality Audits

By Jon Speer on June 4, 2018
  How did your last internal quality audit go?
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification - Featured Image

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018
We have many different types of companies using Greenlight Guru to help them create a compliant qual...
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification - Featured Image

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

By Nick Tippmann on May 25, 2018
It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

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