Three Systems of Risk—Mike on Medtech

Three Systems of Risk—Mike on Medtech

Mike Drues and Sean Fenske highlight the three systems of risk within the medical device manufacturing regulatory landscape and discuss the purpose of each.

By Sean Fenske, Editor-in-Chief09.07.21
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the three systems of risk as they relate to the U.S. regulatory system. While many are familiar with the device classification system, they may not be as familiar with the other two systems or their purpose. Whether or not all three systems are actually needed is also explored. Specifically, the following questions are addressed:

  • First, can you explain how we handle risk in medtech manufacturing in the U.S.?
  • What is the medical device classification system and why do we have it?
  • What is the Significant Risks vs. Non-Significant Risk system?
  • What about software? What is the Software classification system?
  • How are the three systems of risk related?
  • Do we need three separate systems to handle risk?
  • What are the most important items medical device manufacturers need to keep in mind with regard to risk?

Listen to this episode and see what you think of the three systems of risk. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

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