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Ultimate Guide to Clinical Evaluation of a Medical Device in the EU - Featured Image

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

Human Factors & Risk Management: What's Needed & Why? - Featured Image

Human Factors & Risk Management: What's Needed & Why?

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human f...
Your Device is Non-Significant Risk: Now What? - Featured Image

Your Device is Non-Significant Risk: Now What?

If you need to conduct a clinical investigation of your device before it has received market approva...
What is the Best Way to Structure a Risk Management File? - Featured Image

What is the Best Way to Structure a Risk Management File?

The medical device risk management process relies heavily on the use of documentation. Whether the a...
What Should Really Trigger a CAPA? - Featured Image

What Should Really Trigger a CAPA?

Corrective and preventive action (CAPA) is often a thorn in the side of medical device manufacturers...
3 Medical Device Security Challenges (and Solutions) - Featured Image

3 Medical Device Security Challenges (and Solutions)

Technological innovations in and around the medical device industry have made it possible for compan...
3 Non-negotiables for Managing Business Risk as a Medical Device Company - Featured Image

3 Non-negotiables for Managing Business Risk as a Medical Device Company

How seriously do you take risk management? This may seem like an inane question, especially for a pr...
Failure Mode Effects Analysis: What Is It & When Should You Use It? - Featured Image

Failure Mode Effects Analysis: What Is It & When Should You Use It?

Failure mode effects analysis (FMEA) is one of the best-known risk management tools within engineeri...
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist) - Featured Image

How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

So you need to make a change to your medical device, what now?
7 Documentation Musts for All Software Device Premarket Submissions - Featured Image

7 Documentation Musts for All Software Device Premarket Submissions

As the prevalence of software in medical devices and software as medical devices (SaMD) has increase...
3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases - Featured Image

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Too many companies still treat risk management as a “checkbox” activity.
How are Medical Devices Classified under EU MDR? - Featured Image

How are Medical Devices Classified under EU MDR?

One of the most important steps in bringing a medical device to market in the European Union (EU) is...

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