Greenlight Guru Medical Device Blog

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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 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.
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device - Featured Image

When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

Today’s guest is Mike Drues, the president of Vascular Sciences and a world-renowned expert on all t...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
Why Poor Design Controls Mean More Medical Device Complaints - Featured Image

Why Poor Design Controls Mean More Medical Device Complaints

I’ll venture a guess that you want to get your medical device to market ASAP!
Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include - Featured Image

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): Understanding the Differences and What Documents to Include

DHF. DMR. DHR. It’s bad enough that medical device product development has a whole slew of new terms...
8 Reasons Why Your Design Controls And Risk Management Processes Fail - Featured Image

8 Reasons Why Your Design Controls And Risk Management Processes Fail

Design controls and risk management processes should be tools for medtech professionals to ensure th...
Best Practices for an Effective Medical Device Design Transfer Process - Featured Image

Best Practices for an Effective Medical Device Design Transfer Process

With everything there is out there on the subject of Design Controls, you’d expect to find more on t...
Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff - Featured Image

Why Integrating Business Elements into Your Medtech Development Process Is So Important with Therese Graff

On today’s episode of the Global Medical Device podcast, we’re talking about the importance of incor...
Debunking 4 Commonly Held Design Control Myths - Featured Image

Debunking 4 Commonly Held Design Control Myths

The design control struggle is real. What is the struggle, you ask? Design controls are not being us...
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. There’s always something to...
8 Questions That Define Your Medical Device User Needs - Featured Image

8 Questions That Define Your Medical Device User Needs

When people talk about U.S. Food and Drug Administration (FDA) design controls, they often place a l...

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