Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 68,000+ other medical device professionals outperforming their peers.

3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

By Jon Speer on November 25, 2018
In the medical device world, it’s not uncommon to get hung up on documentation. “It takes too much t...
5 Myths Engineers Believe About Quality (and what is really true) - Featured Image

5 Myths Engineers Believe About Quality (and what is really true)

By Jon Speer on November 4, 2018
A well run medical device company is cross-functional in nature. Engineering, quality, regulatory, m...
The Importance of Good Document Management (And How To Do It) - Featured Image

The Importance of Good Document Management (And How To Do It)

By Jon Speer on September 16, 2018
The long-term success of medical device companies depends on the strength of their foundation. Good ...
Greenlight Guru Announces Advanced Document Management - Featured Image

Greenlight Guru Announces Advanced Document Management

By Nick Tippmann on September 5, 2018
Functionality enhances security while maintaining visibility and transparency in medical device qual...
Why Your Company Needs an Electronic Quality Management System - Featured Image

Why Your Company Needs an Electronic Quality Management System

By Jon Speer on August 12, 2018
It’s time to face facts: a paper-based quality management system is no longer an option. 
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities - Featured Image

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

By Jon Speer on September 4, 2017
Understanding the relationship between product risk management and design controls is critical to th...
The Do’s and Don’ts of an FDA Inspection - Featured Image

The Do’s and Don’ts of an FDA Inspection

By Jon Speer on August 28, 2017
FDA has arrived at your premises…
13 Common Pitfalls to Avoid During Medical Device Product Development - Featured Image

13 Common Pitfalls to Avoid During Medical Device Product Development

By Jon Speer on July 9, 2017
Are you falling into some of the common traps that surround medical device product development?
What is a “Quality Data Source” for your CAPA Process? - Featured Image

What is a “Quality Data Source” for your CAPA Process?

By Jon Speer on April 17, 2017
There’s a phrase that the FDA states in their policies around CAPA, which elicits a few questions. T...
5 Places Paper Might Be Hiding in Your Medical Device Company - Featured Image

5 Places Paper Might Be Hiding in Your Medical Device Company

By Jesseca Lyons on July 11, 2016
A few weeks ago you left a big pile of paperwork (also known as your Document Change Order (DCO/ECO)...
4 Medical Device Quality System Musts for Startups - Featured Image

4 Medical Device Quality System Musts for Startups

By Jon Speer on May 31, 2016
Medical device startups have a pile of things to address yet often don’t have the pile of money to t...
3 Tips for Managing Your Medical Device Design History File - Featured Image

3 Tips for Managing Your Medical Device Design History File

By Jon Speer on April 21, 2016
Developing a cutting edge medical device can be really fun and exciting.

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

Our Most Popular Posts

Topics

See More Topics...
© 2019 Greenlight Guru
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. Legal