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

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) - Featured Image

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 - Featured Image

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...
Using the Bucket Method for Medical Device Risk Management - Featured Image

Using the Bucket Method for Medical Device Risk Management

By Nick Tippmann on December 6, 2016
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)

By Nick Tippmann on October 26, 2016
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)

By Nick Tippmann on October 19, 2016
FDA Pre-submissions: They're a hot, timely topic.

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