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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?
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...
5 Tips for Conducting Management Reviews - Featured Image

5 Tips for Conducting Management Reviews

When was your last company management review? If you’re left scratching your head, it either may not...
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.
Technical File vs. 510(k) vs. Design History File: What Medical Device Developer Should Know - Featured Image

Technical File vs. 510(k) vs. Design History File: What Medical Device Developer Should Know

Sometimes it feels like you need to know an entirely new language to work in the medical device fiel...
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device - Featured Image

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Today Jon Speer and Mike Drues are going to be discussing general wellness devices. Mike is the pres...
Understanding the Connection Between Complaints, CAPAs, and MDRs - Featured Image

Understanding the Connection Between Complaints, CAPAs, and MDRs

Today we are going to talk about the connection between complaints, CAPAs, and MDRs. They are all in...
8 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

8 Tips to Comply With FDA 21 CFR Part 11

  When it comes to compliance among medical device companies, there is a lot of misleading informati...
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...
EU-MDR and EU-IVDR are live - Here are some important items you should know! - Featured Image

EU-MDR and EU-IVDR are live - Here are some important items you should know!

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...
A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

Editor's Note: This article was originally published by  Florian Tolkmitt on Medium and is being rep...
Better Root Cause Analysis for Safer, More Effective Medical Devices - Featured Image

Better Root Cause Analysis for Safer, More Effective Medical Devices

Have you really figured out the root cause of any issues found in your medical device company?

The greenlight.guru Medical Device Blog

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