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Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
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...
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 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...
An Overview of What Device Makers Need to Know About CAPA - Featured Image

An Overview of What Device Makers Need to Know About CAPA

Today we will be talking about a topic that seems to be an area of continual concern and, in some ca...
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? - Featured Image

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Do you understand the difference between significant risk and nonsignificant risk when it comes to t...
What Devicemakers Need to Know About Medical Device Reporting (MDR) - Featured Image

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?
2016 Medical Device Regulatory Trends Year in Review - Featured Image

2016 Medical Device Regulatory Trends Year in Review

We’re in the last days of 2016, and it’s a good time to look back as we plan for the future. On toda...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

Risk management: It’s a topic that needs to be navigated carefully by medical device companies. It’s...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two) - Featured Image

What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

FDA Pre-submissions: They're a hot, timely topic.

The greenlight.guru Medical Device Blog

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