<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Greenlight Guru Medical Device Blog

GET THE LATEST UPDATES FROM OUR BLOG:

Join 150,000+ other medical device professionals outperforming their peers.

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!

If there’s no use risk, then no problem! That's what most directives indicate, however, users are un...
Greenlight Guru Announces Multi-Level Design Control Software - Featured Image

Greenlight Guru Announces Multi-Level Design Control Software

Functionality enables visibility into multiple workspaces, holistic view of design components and a ...
The Ultimate Guide To Design Controls For Medical Device Companies - Featured Image

The Ultimate Guide To Design Controls For Medical Device Companies

7 Problems with a Paper-Based Design History File (And How to Avoid Them) - Featured Image

7 Problems with a Paper-Based Design History File (And How to Avoid Them)

If you’re using a paper-based system to manage your design history file (DHF), it can raise several ...
An Overview of What Medical Device Developers Need to Know About Human Factors - Featured Image

An Overview of What Medical Device Developers Need to Know About Human Factors

The topic of human factors can be confusing: How does it relate to design factors and risk? Why is i...
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…
How to Translate Voice of Customer into User Needs - Featured Image

How to Translate Voice of Customer into User Needs

How well do you do at capturing “voice of customer” and translating into user needs?
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen) - Featured Image

How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

So, you haven’t completed your design controls or design history file (DHF)...
How to Prepare Your Design History File (DHF) for an FDA Inspection - Featured Image

How to Prepare Your Design History File (DHF) for an FDA Inspection

  So, the FDA is coming to inspect your medical device company.
Design Validation vs. Clinical Evaluation: What’s the Difference? - Featured Image

Design Validation vs. Clinical Evaluation: What’s the Difference?

How confident are you when it comes to design validation? Does this always involve clinical evaluati...
How to Define and Decode Your Design Inputs and Design Outputs - Featured Image

How to Define and Decode Your Design Inputs and Design Outputs

We’re looking at a topic that confuses a lot of medical device developers.

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...