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3 Real World Document Management Horror Stories - Featured Image

3 Real World Document Management Horror Stories

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)

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)

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

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

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

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

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

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?

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

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

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

Developing a cutting edge medical device can be really fun and exciting.

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

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