See the Demo

Greenlight Guru Medical Device Blog

Get the latest updates from our blog:

Nick Tippmann

Nick Tippmann
Nick is the VP of Marketing at Greenlight Guru, the only quality management software platform designed specifically for medical device companies.
Connect with me:
https://www.linkedin.com/in/nicktippmann http://www.twitter.com/greenlightguru nick.tippmann@greenlight.guru http://www.greenlight.guru/

Author's Posts

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

By Nick Tippmann on November 8, 2017
The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes - Featured Image

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

By Nick Tippmann on October 30, 2017
The only eQMS specifically for medical device will enable companies to move beyond baseline complian...
Lessons to Be Learned from Recent FDA Inspections - Featured Image

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) - Featured Image

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 - Featured Image

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...
How Process Excellence Leads to Product Excellence - Featured Image

How Process Excellence Leads to Product Excellence

By Nick Tippmann on August 2, 2017
Today, we are talking to Mike Fisher, who is the director of product development at the Global Cente...
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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...
How FDA Interacts with Medical Devices When They Are Imported Into the US - Featured Image

How FDA Interacts with Medical Devices When They Are Imported Into the US

By Nick Tippmann on April 5, 2017
Does your medical device company import components, parts, or materials used in the development or m...

The Greenlight Guru Medical Device Blog

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

Our Most Popular Posts

Topics

See More Topics...
© 2018 Greenlight Guru
Third party trademarks, logos and trade names appearing on the site are the property of their respective owners. Legal