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
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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
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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
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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
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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
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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
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20mins
