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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 Intersection of Medical Device Usability and Risk Management - Featured Image

The Intersection of Medical Device Usability and Risk Management

Today we’re going to be talking to our good friend Mike Drues from Vascular Sciences about the inter...
CAPA: When to Take Corrective Action or Preventive Action? - Featured Image

CAPA: When to Take Corrective Action or Preventive Action?

How many of you can confidently initiate a CAPA and know exactly how and what to do and the process ...
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...
Tips for Conducting Better Root Cause Analysis for Medical Device Companies - Featured Image

Tips for Conducting Better Root Cause Analysis for Medical Device Companies

At some point, every medical device development company will encounter an issue that requires an inv...
This is a What … Unforeseen Pitfalls when Classifying a Medical Device - Featured Image

This is a What … Unforeseen Pitfalls when Classifying a Medical Device

“This is a what” is not only a torturous summer-camp game, but an essential question when working to...

The greenlight.guru Medical Device Blog

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