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Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway - Featured Image

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

By Nick Tippmann on January 10, 2018
This past month, the FDA drafted a guidance on a quick path to approval as an alternative to the 510...
Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

By Nick Tippmann on November 16, 2017
Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
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...
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...
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, Jon Speer is talking to Mike Drues, who is a frequent gu...
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...
An Overview of What Device Makers Need to Know About CAPA - Featured Image

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...

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