Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Lessons to Be Learned from Recent FDA Inspections

By Nick Tippmann on October 18, 2017

Something that you might find surprising is the number of medical device companies that are simply n...

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

By Nick Tippmann on August 30, 2017

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

By Nick Tippmann on August 18, 2017

It can be confusing to know which submission type is the correct one for your particular development...

Understanding FDA’s Proposed Conformity Assessment Pilot Program

By Nick Tippmann on July 21, 2017

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

By Nick Tippmann on May 31, 2017

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

By Nick Tippmann on May 24, 2017

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

By Nick Tippmann on May 17, 2017

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

By Nick Tippmann on April 27, 2017

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

By Nick Tippmann on March 15, 2017

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?

By Nick Tippmann on February 14, 2017

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)

By Nick Tippmann on January 25, 2017

Medical device reporting, or MDR: what is it? What isn’t it? Why is it important?

2016 Medical Device Regulatory Trends Year in Review

By Nick Tippmann on December 29, 2016

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...

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