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Greenlight Guru Medical Device Blog

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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.
Acronyms You Need To Know When Evaluating Medical Device Software Solutions - Featured Image

Acronyms You Need To Know When Evaluating Medical Device Software Solutions

Ah, yes! You aspire to run your device company in a paperless environment. Allowing you to capture a...
Top 3 Document Management Tips for Medical Device Companies - Featured Image

Top 3 Document Management Tips for Medical Device Companies

In the medical device industry, one absolute—which shows no signs of abating—is the need to maintain...
Best Document Management Practices for Medical Device Startups: Don’t Cheap Out - Featured Image

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

Vendor-supplied document management systems have loads of advantages that even the youngest startup ...

The Greenlight Guru Medical Device Blog

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

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