Mike Drues

6 Podcast Episodes

How Jon Speer Met His Most Frequent Guest: Mike Drues

How Jon Speer Met His Most Frequent Guest: Mike Drues

Reminiscing about past and present lessons learned from listening to conversations with this show’s most frequent guest,... Read more

26 Aug 2020

40mins

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Risk management: It’s a topic that needs to be navigated carefully by medical device companies.It’s been gaining a lot o... Read more

6 Dec 2016

34mins

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Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

When it comes to moving from the conceptual phase of developing a medical device and actually doing first in-human studi... Read more

4 Oct 2016

32mins

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

In order to get your medical device to market, you will need to know about pre-submission and the pre-submission process... Read more

31 Aug 2016

30mins

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What Device Makers Need to Know About Design Verification and Validation with Mike Drues

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Here’s a question for our listeners: When it comes to making sure your medical devices are safe and effective, is it mor... Read more

10 May 2016

31mins

The Difference Between Intended Use and Indications of Use with Mike Drues

The Difference Between Intended Use and Indications of Use with Mike Drues

It’s time to break down the how and why of intended use and indications of use statements for your new medical device. O... Read more

19 Apr 2016

20mins

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