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Mike on Medtech

Measuring Regulatory/Quality Team Member Performance—Mike on Medtech

Mike Drues and Sean Fenske share ideas and best practices for measuring performance, and also how much to trust these company members.

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By: Sean Fenske

Editor-in-Chief, MPO/ODT
Measuring Regulatory/Quality Team Member Performance—Mike on Medtech

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about how to best determine the efficacy of regulatory and quality team members. A variety of real-world examples are provided that demonstrate the need to “trust but verify” the actions of these team members. During this conversation, the following questions are addressed:

  • Why the need to measure the safety and efficacy of the regulatory and quality team?
  • What can happen if you put too much trust or reliance on your regulatory consultant?
  • Can you give a specific example where there was too much trust?
  • Can you give us another regulatory example, perhaps involving clinical trials?
  • Can you provide a quality or manufacturing example, perhaps involving AI?
  • What are today’s takeaways?

Listen to this discussion and see if you need a plan to verify your regulatory and quality team members’ actions. 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 your ideas/inquiries/suggestions align with a future episode.

Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify.

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